OTC Review and Outlook

SPECIAL REPORT MARCH 2011

OTC review AND Outlook

Gl o b a l g r o w t h b e i n g d r i v e n b y e m e r g i n g m a r k e t s

The global market for consumer-care products generated slower growth in 2010 than during the previous year, partially because of a weaker flu season in North America and Europe. However, emerging markets for OTC products continue to expand, lead by China. The markets in India and Latin America also remain on a solid growth pattern.

Driving forces in the U.S. over-the-counter market include Rx-to-OTC switches of former blockbuster brands as well as consumers’ increasing usage of self medication. More than 300,000 OTC products are on the U.S. market, separated by the Food and Drug Administration into 80-plus classes based on their intended therapeutic uses. Leading therapeutic categories/medical-usage areas for OTC products include cholesterol therapy; contraception; cough, cold and allergy; dermatology; gastrointestinal disorders; pain management; sexual dysfunction; and weight management/obesity.

This first-time special report provides an overview of the worldwide consumer healthcare arena, profiles of some of the leading OTC companies, and various listings including FDA over-the-counter approvals as well as Rx-to-OTC switches. UBM Canon DATA PRODUCTS TABLE OF CONTENTS 828 Newtown-Yardley Road, Suite B Newtown, PA 18940 United States Phone: +1.215.944.9800 Global OTC Market Overview...... 3 Fax: +1.215.867.0053 Website: PharmaLive.com Rx And OTC Product Company Leaders...... 3 Roger Burg VP, Operations Gastrointestinal Disorders...... 15 Publications Division [email protected] Allergies...... 16 +1.310.445.4221 Glenn Glasberg Other Acquisitions...... 16 Circulation and Marketing Director [email protected] Dosing Controversy...... 17 +1.215.944.9810 Sandra Baker OTC Company Review...... 17 Data Products Manager [email protected] FDA OTC Approvals On The Market: By Action Date...... 32 +1.215.944.9836 Jennifer Schlegel FDA OTC Approvals On The Market: By Company...... 48 Assistant Marketing Manager [email protected] Ingredients & Dosages Transferred From Rx-to-OTC Status +1.215.944.9821 (or New OTC Approvals) by FDA Since 1975...... 65 Amanda Wells Assistant Marketing Manager [email protected] OTC Product U.S. Patent Data: By Company...... 69 +1.215.944.9840 OTC Devices By Class...... 80 Daniel Croak Marketing Assistant [email protected] +1.215.944.9809 Andrew Humphreys Editor In Chief, Data Products Review the most recent Special Reports at: [email protected] www.PharmaLive.com/SpecialReports +1.215.944.9812 Stefanie Fedder Manager, Data and Content See these and other topics: [email protected] +1.215.944.9807 Pain Management Review and Outlook Silvia Arriola M&A, Partnerships, and Collaborations Review and Outlook Data Specialist [email protected] Women’s Health Review and Outlook +1.215.944.9803 Top 20 Company Pipelines Diane Strohm Data Specialist Drug Patent Review and Outlook [email protected] +1.215.944.9828 Top 15 Therapeutic Groups Andrew Ellison Wound Care Review and Outlook Data Specialist [email protected] Top 50 Specialty Companies +1.215.944.9826

Rebecca Mayer Contributing editor eKnowledgeBase – searchable pipeline and business-information Kim Stannard Production assistant database for the world’s pharma & biotech companies. Request a trial at: www.PharmaLive.com/newEKB UBM Ltd. Corporate Head Office Ludgate House 245 Blackfriars Road MDRWeb.com – searchable database of global medical device London, SE1 9UY, United Kingdom Phone: +44 (0) 20 7921 5000 companies and their products. Website: ubm.com Learn more at: www.MDRWeb.com – enter promo code UBM Canon Headquarters SRTRIAL for free two-week trial access. 11444 W. Olympic Blvd. Los Angeles, CA 90064 United States Phone: +1.310.445.4200 For more information about these products, please contact: Fax: +1.310.445.4299 Website: ubmcanon.com [email protected] or call: +1-215-944-9836

2 OTC Review and Outlook

The Global OTC Market This grouping includes some blockbuster pages detail them and their consumer- prescription brands. For a listing of these health developments and strategies. The worldwide consumer-care market products, please see page 65. grew more slowly in 2010 versus 2009. This Another market driver is the growth in Johnson & Johnson performance was due mainly to a weak self medication by consumers. Each year flu season in Europe and North America. consumers increasingly become more J&J has 250-plus operating companies The worldwide OTC market value in 2010 willing and better able to medicate them- in 57 countries and 114,000 employees. was about $115 billion, led by cough and selves with the help of online sites and oth- Johnson & Johnson has a diverse range cold preparations at around $20 billion. er resources. With this easily accessible of consumer products, prescription medi- In terms of OTC market value for certain and increased knowledge comes more cines, and medical devices and diagnos- global markets: self medication with OTC products. tics marketed around the globe. • The United States was estimated to Plus, with traditional healthcare costs J&J reported 2010 global sales total- have topped $30 billion in 2010 and could rising higher, the aging population is in- ing $61.6 billion, down 0.5% compared to exceed $35 billion in 2012. creasingly looking for alternative self-care 2009. Global Consumer sales amounted • Europe generated about $44 billion treatments. And as the overall population to $14.59 billion in 2010, a 7.7% decline ver- in 2010. South Europe (Portugal, Spain, Ita- trends toward a healthier lifestyle, OTC sus the previous year. There was an oper- ly, Greece and France) comes in at about products are becoming more popular. ational decrease of 8.9% and a positive 6.5 billion euros in a mature but extreme- The leading therapeutic categories/ impact from currency of 1.2% for this busi- ly fragmented region. Eastern Europe medical-usage areas for OTC products ness segment in 2010. Domestic sales were (Czech Republic, Poland, Romania, Bul- include cholesterol therapy; contracep- down 19.3% to $5.52 billion versus 2009. In- garia, Hungary, Slovakia) registers more tion; cough, cold and allergy; dermatol- ternational sales grew 1.2% to $9.07 billion, than 2 billion euros, with some countries ogy; gastrointestinal disorders; pain man- reflecting an operational drop of 1% and generating annual double-digit growth. agement; sexual dysfunction; and weight a positive currency impact of 2.2%. • BRIC (Brazil, Russia, India and China) management/obesity. According to J&J, it is the world’s sixth- countries combined to produce about Also helping drive the OTC landscape largest consumer-healthcare company. $21 billion for 2010 and are on track to is the U.S. dietary supplement industry, J&J’s Consumer business breaks down near $24 billion in 2012. which is valued at about $25.2 billion. This into six segments. Sales in 2010 for OTC/ • Japan generated more than $12 bil- market is growing at a double-digit com- Nutritionals decreased 19.2% year over lion during 2010, but annual growth is in pound annual growth rate. year to $4.55 billion. Global Skin Care sales the low single digits. totaled $3.45 billion in 2010, down 0.4% Companies that are Rx Brand versus 2009. Baby Care sales amounted A significant factor driving the OTC are- Leaders and OTC Product Leaders to $2.21 billion, up 4.4%. Women’s Health na is emerging markets. During 2010, de- sales dropped 2.7% to $1.84 billion. Oral mand for consumer-care products in Chi- Seven of the top 10 pharma/biopharma Care sales also dropped 2.7% in 2010, na and India markedly improved. China companies based on 2009 revenue have coming in at $1.53 billion. In the Wound is considered the No. 2 consumer health- a leading consumer-healthcare business: Care/Other segment, sales in 2010 totaled care country after the United States. Sol- Johnson & Johnson, Pfizer Inc., GlaxoS- $1.01 billion, down 10.4% versus 2009. id market growth was registered in Latin mithKline Plc., Novartis AG, sanofi-aven- J&J’s overall worldwide Consumer America and other parts of Asia in 2010. tis, Merck & Co., and Bayer. The following sales performance was significantly im- In addition to emerging markets, Rx-to- OTC switches will significantly help drive Johnson & Johnson the consumer-health marketplace forward in the years to come. Because over- the-counter medicines are cost-effective first-line therapies for many ailments, the Rx-to-OTC switch process has a positive impact on America’s healthcare system process by driving down overall healthcare costs. For instance, according to a study performed by researchers at North- western University, using OTC products to treat certain upper respiratory infections could save $4.75 billion per year. More than 100 ingredients and dosage strengths have been switched from Rx to OTC status or have been newly ap- Source: Johnson & Johnson proved by FDA during the past 35 years. 3 pacted by the previously announced re- Both recalls were initiated at the whole- ports of diarrhea, nausea and vomiting calls of certain OTC medicines and the sale level. No action is required by con- after people used the products. suspension of manufacturing at the Mc- sumers or healthcare providers, and con- J&J provided an update in January Neil Consumer Healthcare Fort Wash- sumers can continue to use the products. 2011 regarding McNeil Consumer Health- ington, Pa., facility as well as the curren- These actions were not undertaken on the care remediation and announced com- cy devaluation in Venezuela. basis of adverse events. pletion of the internal assessment phase With respect to the McNeil Consum- McNeil identified the inadequacies of the comprehensive action plan. In July er Healthcare product recalls, J&J CEO as part of a thorough, proactive prod- 2010, McNeil Consumer filed with FDA a William C. Weldon said on Jan. 25, 2011, uct quality and process assessment of all Comprehensive Action Plan on quality im- “We have made a commitment to restor- of its produced products. McNeil has improvement and “made a commitment to ing these products to the levels of quality plemented a Comprehensive Action Plan restore its operations to the level of quality and compliance that consumers expect at its U.S. manufacturing sites to improve and compliance that people expect of of Johnson & Johnson.” the quality systems at those locations. This all Johnson & Johnson companies.” McNeil-PPC Inc.’s McNeil Consumer product assessment is a key milestone in As part of this commitment, McNeil un- Healthcare in January 2011 began vol- the plan’s implementation, and the ac- dertook a thorough investigation of his- untarily recalling at the wholesale lev- tions undertaken as a result of the as- torical records dating back to 2007 for el certain lots of Tylenol 8 Hour, Tylenol sessment are part of McNeil’s continuing products sold in America and produced Arthritis Pain, and Tylenol upper-respira- commitment to ensure that all its products in McNeil’s internal manufacturing net- tory products. Also voluntarily recalled are meet the high quality standards expect- work. For every product, McNeil looked certain lots of Benadryl, Sudafed PE, and ed by consumers. at whether the right processes had been Sinutab products. The impacted regions During November 2010, J&J recalled identified and followed, and evaluat- are the U.S., Caribbean, and Brazil. about 4 million packages of Children’s ed whether quality standards had been These products were manufactured Benadryl allergy tablets and roughly met. This assessment has been complet- at the McNeil plant in Fort Washington, 800,000 bottles of junior-strength Motrin ed, which is a important milestone in the Pa., before April 2010, when production caplets due to manufacturing lapses. Comprehensive Action Plan. at the facility was halted. McNeil is initiat- J&J’s McNeil unit withdrew more than The assessment identified various ar- ing the recall as a precautionary measure 40 types of children’s OTC liquid medi- eas for improvement that are being ad- after an extensive review of past produc- cines during April 2010, forcing a suspen- dressed. For example, McNeil identified tion records pinpointed instances where sion of production at a manufacturing instances in which equipment cleaning equipment cleaning procedures were in- plant. As a result, 2010 sales were reduced procedures were insufficient or cleaning sufficient or that cleaning was not ade- by about $600 million, according to indus- were inadequately documented. These quately documented. J&J said it is very try reports. The U.S. House Oversight and issues took place at McNeil’s Fort Wash- unlikely that this impacted the quality of Government Reform Committee has in- ington, Pa., manufacturing plant, before these products. vestigated Johnson & Johnson’s recall April 2010 when production halted. McNeil Consumer Healthcare addi- handling as well as a separate incident McNeil additionally discovered one tionally initiated as of January 2011 a vol- involving Motrin tablets. product for which the labeling did not in- untary recall of certain product lots of In January 2010, J&J pulled 500 lots of clude all info required by regulations. In Rolaids Multi-Symptom Berry Tablets drugs, including Rolaids, Motrin and some line with the company’s unqualified ded- distributed in the United States to update types of Tylenol, because of possible con- ication to quality and compliance, Mc- the labeling. McNeil initiated the recall af- tamination from a chemical on shipping Neil announced in January 2011 a whole- ter determining that the product labeling and packing materials. That recall was sale-level recall of products affected by does not include the language “Does not expanded in June 2010 after consumer these issues. This recall did not result from meet USP” as required by regulation. complaints of a musty odor as well as re- adverse events. “Steps we have taken under the Com- Johnson & Johnson prehensive Action Plan constitute an un- compromising and systematic effort to review quality and manufacturing prac- tices at McNeil,” Mr. Weldon stated. “They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expecta- tions that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world.” As a continuing part of this effort, Mc- Neil is performing assessments at other locations that manufacture its products. If these reviews point out any additional issues, McNeil intends to take whatever Source: Johnson & Johnson steps are necessary to ensure that its prod- 4 ucts meet world-class quality standards, assessed on the forearms of healthy males Bioelectricity is the body’s native elec- including potential market action. and females older than 18 years. The trical signaling process that helps direct During February 2011, Johnson & technology was compared to untreat- physiological activities at the cellular level, Johnson Consumer Companies Inc.’s ed skin, zinc oxide as well as zinc chlo- including the skin’s own rejuvenation pro- breakthrough Cytomimic Technolo- ride. After cleansing, a small amount of cess. Applied topically, Cytomimic Tech- gy was featured in a scientific poster at each material was placed within defined nology can aid in the rejuvenation and the 69th Annual Meeting of the Amer- 1.5-mm diameter circles and measured maintenance of healthy-looking skin. ican Academy of Dermatology in New for electric fields covering the skin using As people age bioelectrical signals Orleans. This esteemed, award-winning, a non-invasive instrument based on a vi- naturally diminish, which can result in de- innovative technology stems from de- brating probe technique. This technolo- creased cell-to-cell communication, pro- cades of research to harness the power gy has shown anti-inflammatory activity, duction of essential proteins such as col- of bioelectricity to improve skin rejuvena- collagen and elastin production, and clin- lagen and elastin, and in healing abilities. tion. Cytomimic Technology will addition- ically proven safety and effectiveness in This can lead to fine lines and wrinkles, loss ally be featured in scientific exhibits at the reducing photoaging signs. of firmness and sagging skin. World Congress of Dermatology in Seoul, “Bioelectricity is found in every single The science of Cytomimic is centered Korea during May 2011. body system and cell in the body,” Dr. Sun on creating and delivering biological lev- “Just one year after the unveiling of Cy- stated. “Combining this knowledge with els of electricity directly to the skin, natu- tomimic Technology for use in anti-aging our innovative technology, we can po- rally stimulating the intrinsic rejuvenation at this prestigious forum, we are excited tentially continue to expand and find new process. This innovation is based on the to present new clinical data on its poten- uses and platforms for Cytomimic Tech- design of a proprietary technology – en- tial to stimulate tissue repair,” stated Dr. nology to address countless additional ergized micro-particles of zinc and cop- Ying Sun, a Distinguished Research Fellow needs in tissue repair applications.” per – captured in a unique delivery sys- and Science Leader at Johnson & John- The clinical trial shows that the topi- tem that assists in stimulating the body’s son Consumer Companies. “Injured skin cal application of biomimetic signaling own rejuvenation processes. When acti- naturally generates a low level electrical technology to the skin provides an elec- vated by moisture, these energized mi- signal to promote healing. The applica- tric field profile similar to that of the en- cro-particles act as “miniaturized batter- tion of Cytomimic technology has clinical- dogenous electric field that the skin gen- ies” that aid in jump-starting healthy skin ly demonstrated the ability to mimic this erates at a wound site. function. These micro-particles remain on healing signal for potential tissue healing This patented technology was dis- the skin’s surface and mimic the body’s and rejuvenation applications.” covered in 2004 by Dr. Sun and his col- native electrical signals, to rebuild and re- A clinical trial was performed to deter- leagues Dr. Jue-Chen Liu and Jeannette store youthful-looking skin. mine if the biomimetic technology mim- Chantalat. Johnson & Johnson Consum- Cytomimic represents a major ad- ics the endogenous healing signal gener- er Companies holds 10 U.S. patents for this vancement in skin care as the first tech- ated by the skin. Cytomimic Technology, technology, which are active until 2023. nology designed to deliver electricity at a consisting of a proprietary galvanic cou- Multiple U.S. and international applica- scale that safely simulates the body’s own pling of elemental zinc and copper, was tions are pending. bioelectricity levels in the form of a topical treatment. This leads to improved cell activity, evidenced in vitro by enhanced ex- J&J’s Consumer segment includes a wide array of products used in the baby care, skin care, oral care, wound care and women’s healthcare fields, as well pression of collagen and elastin; acceler- as nutritional & OTC pharma products and wellness & prevention platforms. ated improvement in reducing the signs of aging, even in the delicate skin around • The Baby Care franchise includes the JOHNSON’S Baby line of products. the eyes; improved skin texture, firmness • Major brands in the Skin Care franchise include the AVEENO; CLEAN & and radiance; and demonstrated anti-in- CLEAR; JOHNSON’S Adult; NEUTROGENA; RoC; LUBRIDERM; DABAO; and flammatory activity to address a poten- Vendôme product lines. tial cause of aging • The Oral Care franchise includes the LISTERINE and REACH oral care lines of J&J Consumer Companies has eval- products. uated Cytomimic on 1,000-plus individu- • The Wound Care franchise includes BANDAID brand adhesive bandages als/subjects in clinical and safety trials for and Neosporin First Aid products. • Major brands in the Women’s Health franchise are the CAREFREE Pantiliners; more than 3.5 years. The technology has o.b. tampons and STAYFREE sanitary protection products. shown improvement of the skin’s appear- • The nutritional and over-the-counter lines include SPLENDA , No Calorie ance within minutes of application and Sweetener; the broad family of TYLENOL acetaminophen products; SUDAFED continued improvements over time. cold, flu and allergy products; ZYRTEC allergy products; MOTRIN IB ibuprofen Cytomimic is clinically proven to signifi- products; and PEPCID AC Acid Controller from Johnson & Johnson • Merck cantly reduce the hallmark signs of aging, Consumer Pharmaceuticals Co. in some cases in as little time as 30 minutes, by diminishing the appearance of bags These products are marketed to the general public and sold to retail outlets and distributors worldwide. under the eyes and periorbital fine lines and wrinkles; reducing the look of dark Source: Johnson & Johnson circles; reducing the look of fine lines and wrinkles; lifting appearance of the eyes; 5 Copenhagen, Denmark-based Fer- The Pfizer Consumer Healthcare business includes the following types of OTC products: pain-management therapies, cough/cold/allergy remedies, rosan is an innovative and long-estab- dietary supplements, hemorrhoidal care, and other personal-care items. lished consumer healthcare company with a portfolio of leading brands. Since • Dietary supplements include Centrum brands (including Centrum, Centrum 1920, the company has grown to serve Silver, Centrum Men’s and Women’s, Centrum Performance, Centrum Cardio a broader market including Russia, the and Centrum Kids) and Caltrate. Ukraine, Poland, Turkey and many coun- • Pain management consists of the Advil brands (including Advil, Advil tries in Central and Eastern Europe. PM, Advil Liqui−Gels, Children’s Advil, Infant’s Advil, Advil Migraine) and “Ferrosan is an excellent strategic fit ThermaCare. that strengthens our presence in dietary • The Respiratory line contains Robitussin, Advil Cold & Sinus, Advil Congestion supplements with a new set of compel- Relief, and Dimetapp. • The Personal Care segment includes ChapStick and Preparation H. ling brands and product pipeline,” stated Paul Sturman, president, Pfizer Consum- Source: Pfizer er. “The transaction will mark an important step towards expanding Ferrosan’s brands through Pfizer’s global footprint. As reducing the appearance of crow’s feet Advil, the calcium supplement Caltrate an immediate result of this acquisition, we wrinkles; improving radiance and bright- and the multivitamin Centrum. will gain greater distribution and scale for ness; lifting, firming, and enhancing the According to Pfizer, its Consumer Pfizer’s well-known brands such as Cen- look of jawline contours; and improving Healthcare business ranks No. 5 among trum and Caltrate in Ferrosan’s regions.” skin softness and smoothness. all OTC entities worldwide. Pfizer sells two Ferrosan’s product portfolio includes of the world’s top 10 selling OTC brands, Multi-tabs, a popular multivitamin brand, Pfizer Centrum and Advil. The Consumer Health- Bifiform, a leading probiotic, Fri Flyt/Ac- care unit has strong positions in various tive Omega, an Omega 3 product, and New York-based Pfizer’s diversified world- geographic markets, with its highest rev- Imedeen premium oral skin-care brands. wide healthcare portfolio includes hu- enue volume in the U.S., Canada, China, These brands rank among the top-selling man and animal biologic and small-mol- Italy, Germany, Brazil and Australia. products in their respective categories. ecule medicines and vaccines, nutritional Pfizer agreed during February 2011 According to Ferrosan President Ola products, and many well-known consum- to buy Ferrosan’s consumer healthcare Erici, “We are very pleased that Ferrosan’s er brands. Pfizer’s 2010 revenue came in business from Altor 2003 Fund GP Ltd. Fer- innovative portfolio of leading brands will at $67.8 billion, up 36% versus the 2009 rosan’s portfolio includes dietary supple- be joining Pfizer. We expect that, as part amount. Revenue for 2010 was signifi- ments and lifestyle products. of the Pfizer portfolio, our products will cantly impacted by $18.1 billion, or 37%, GlaxoSmithKline due to legacy Wy- eth products, and by $1.1 billion, or 2%, due to foreign exchange. The performance was negatively impacted by $1.4 billion, or 3%, due to legacy Pfizer products. Pfizer in 2009 acquired the biopharma giant Wyeth, which was an active OTC player. Wyeth’s consumer healthcare business is reflected in the significant growth generated by Pfizer Con- sumer Healthcare during 2010. Sales for the Pfizer business segment totaled $2.77 billion compared to $494 million during 2009. Wy- eth OTC products in- Source: GlaxoSmithKline clude the pain reliever 6 build on their industry-leading positions GSK maintains leading positions in all of product is being launched in 50-plus Euro- and become available in more coun- the company’s key consumer product ar- pean and International markets in 2011. tries around the world. And, at the same eas. On a global scale, GSK ranks No. 2 in The breakthrough formulation is the time, Pfizer will be able to leverage its foot- OTC medicines and No. 3 in Oral health- first everyday fluoride toothpaste that print in key Ferrosan markets with new Pfiz- care. GSK’s Nutritional healthcare is No. 1 contains patented NovaMin technolo- er products.” in the U.K., Ireland and India. gy. This technology is scientifically prov- The deal is subject to customary closing According to GSK, the leading force en to repair sensitive teeth by forming a conditions. The transaction is anticipated behind its consumer-healthcare business tooth-like layer over exposed dentine. This to be completed in second-quarter 2011. is science. The company has four dedi- process helps continually repair and pro- Financial terms were undisclosed. cated consumer-healthcare R&D centres tect sensitive areas. and consumer-healthcare regulatory af- Sensitive teeth are common, affecting GlaxoSmithKline fairs. The business segment offers lead- 81% of U.K. adults. However, many do not ing-edge capability in scientific innova- know that the twinges they experience GSK is one of the top research-based phar- tion and marketing excellence. are a sign of sensitivity that results from ma companies worldwide. GSK’s turnover GSK’s consumer-healthcare business exposed dentine. Rather than address- for 2010 decreased 1% to £28.4 billion, with includes well-known brands such as Pan- ing the problem, many sufferers attempt pharma down 2% year over year to £23.4 adol for pain relief, NiQuitin for smoking to ignore the twinges or develop ways to billion. Consumer Healthcare sales in 2010 cessation, and the oral healthcare prod- avoid them, without realizing that their advanced 5% versus 2009 to £5.01 billion. ucts Aquafresh and. Sensodyne. teeth have vulnerable areas. According to the company, the 5% im- In 2010, GlaxoSmithKline announced “Tooth sensitivity is caused when the provement significantly outpaced mar- that its Consumer Healthcare segment dentine is exposed,” according to Profes- ket growth estimated to be 2%. going forward will have an increased sor David Bartlett. “This dentine that makes OTC medicines represented GSK’s concentration around ‘priority’ brands up most of the tooth is porous, with thou- leading Consumer Healthcare segment and emerging markets. Additionally, sands of tiny channels running through it in 2010 with sales of £2.46 billion, up 3% non-core OTC brands with yearly sales of to a nerve in the center. A layer of hard at constant exchange rates. Oral health- roughly £500 million will be divested. enamel on the crown of a tooth protects care sales in 2010 were £1.6 billion (up 6% On March 1, 2011, GlaxoSmithKline the underlying dentine, but if this dentine CER). Nutritional healthcare came in at Consumer Healthcare introduced new is exposed, a tooth can become sensitive £952 million (up 9% CER). Sensodyne Repair & Protect. The new and vulnerable.”

GlaxoSmithKline Consumer Healthcare Products Brand Products Application Markets Competition Oral healthcare Aquafresh toothpastes, toothbrushes, prevention of caries, gum global Colgate-Palmolive’s mouthwashes disease and bad breath Colgate, Procter & Gamble’s Crest Sensodyne toothpastes, toothbrushes prevention of dental global Colgate-Palmolive sensitivity sensitivity toothpastes Biotene mouthwash, gel treat dry mouth many markets none Polident, Poligrip, denture adhesive, denture to improve comfort of fitted global Fixodent Corega cleanser dentures and to clean dentures OTC medicines Panadol tablets, capulets, infant paracetamol-based global, except U.S. Nurofen drops treatment of headache and joint pain, fever, cold symptoms NicoDerm, NiQuitin gum, patch, mini lozenge, treatment of nicotine global Novartis’ Nicotinell, CQ, Nicabate; original lozenge withdrawal as an aid to retailers’ own brands also Nicorette quitting smoking (U.S. only) Nutritional healthcare Lucozade energy and sports drinks energy and hydration U.K., Ireland, some various sports drinks other markets Horlicks malted, milk-based drinks nutrition U.K., Ireland, India Ovaltine, Milo and foods Ribena blackcurrant juice-based vitamin C-delivering health U.K., Ireland, some Robinsons drink drink other markets Source: GlaxoSmithKline 7 The NovaMin technology was initial- Novartis OTC and Animal Health, by streamlin- ly developed to help stimulate bone re- ing and simplifying our decision-making generation, which seeks out the regions Concentrated purely on healthcare, No- process,” Mr. Jimenez stated on Feb. 17, of teeth that are sensitive. The technolo- vartis’ diverse product portfolio includes 2011. “We look forward to Naomi joining gy forms a tooth-like layer over exposed innovative medicines, cost-saving ge- our leadership team – her experience in dentine that is 50% harder than healthy neric pharmaceuticals, preventive vac- consumer businesses, combined with her dentine, helping to continually repair and cines, diagnostic tools and consumer- drive for results make her well suited to run protect with twice-a-day brushing. health products. Novartis claims to be the our OTC business.” NovaMin reacts rapidly with water, so a only company with top markets positions Novartis Group’s continuing operations challenge for GlaxoSmithKline Consumer in these fields. generated 2010 net sales of $50.6 billion. Healthcare was to develop a non-water In February 2011, Novartis announced Novartis invested $9.1 billion (or $8.1 billion based formula that could be used in an that its Consumer Health division would be excluding impairment and amortization everyday fluoride-based toothpaste. Af- separated into two segments: OTC and charges) on R&D during 2010. With head- ter being exposed to water or saliva, No- Animal Health. The separate businesses quarters in Basel, Switzerland, Novartis em- vaMin releases calcium and phosphate join these already-established Novartis di- ploys 119,000 full-time-equivalent associ- ions, which are the building blocks for visions: Pharmaceuticals, Sandoz (generates (including 16,700 Alcon associates) teeth that are naturally attracted to ex- ics), and Vaccines & Diagnostics. Addi- and operate in 140-plus countries. posed dentine. The ions bind themselves tionally, following the completion of the Novartis’ Consumer Health sales for to the collagen in the exposed dentine, merger between Novartis and Alcon Inc., 2010 totaled $6.2 billion, up 7% (+6% cc) and from first use, start to form a protec- Ciba Vision Corp. and Novartis ophthal- versus 2009. All of the Consumer Health tive mineral layer that mimics the tooth’s mic medicines will be combined into the businesses generated growth ahead of natural make-up. new Alcon eye-care division. their respective markets for 2010. “Sensodyne Repair & Protect is a tech- As of March 2, 2011 Naomi Kelman is According to Novartis, the group’s OTC nological advance in everyday dental heading the Novartis OTC Division and has business ranked No. 4 in the global sec- care,” according to Dr. Teresa Layer, VP become a permanent attendee to the Ex- tor during 2010. All regions contributed of Oral Healthcare R&D Future Teams for ecutive Committee of Novartis (ECN). Ms. to Novartis’ 2010 sales growth in the OTC GlaxoSmithKline Consumer Healthcare. Kelman reports to Novartis CEO Joseph segment (+5% cc), supported by dou- “With twice-daily brushing it helps to con- Jimenez. Ms. Kelman came to Novartis ble-digit increases of the key brands Vol- tinuously repair exposed dentine and pro- from Johnson & Johnson, where she held taren, Nicotinell and Excedrin. Voltaren vides substantive protection from sensitiv- several leadership roles within the Con- Gel gained FDA clearance during No- ity.” sumer and Medical Device & Diagnostic vember 2007 as the first approved topi- Sensodyne Repair & Protect should sectors. Her successful leadership span- cal prescription treatment for pain asso- be used twice a day like a regular tooth- ning several businesses showed a strong ciated with osteoarthritis. Nicotinell is a paste, which will continually help repair concentration on innovation, and as a re- Nicotine Replacement Therapy (NRT) for sensitive teeth and help prevent sensitivi- sult delivered strong financial results. treating smoking addiction. Excedrin has ty. The product additionally provides the “With the upcoming Alcon merger, we been a leader in headache pain for al- benefits of an ordinary daily fluoride tooth- have decided to put additional focus on most 50 years. paste, such as all-round protection, clean- two important businesses which today During second-quarter 2010, the heart- ing and freshness. comprise the Consumer Health Division: burn treatment Pantoloc Control was successfully introduced in 14 European Novartis markets. Pantoloc Control is anticipated to continue to support growth in No- vartis’ gastrointestinal franchise. Novartis launched the OTC proton-pump inhibitor (PPI) through a joint-marketing pact with the product’s originator Nycomed. Based in Zurich, Switzerland, Nycomed is a privately owned, worldwide pharma company. During 2009, Nycomed ranked No. 28 among global pharma companies and was the 16th-largest provider of OTC medicines, according to the company. For more details about Nycomed, please see page 26. Pantoprazole is the first PPI and second product ever approved by the European Medicines Agency’s Committee for Me- dicinal Products for Human Use for OTC status through the EU’s centralized pro- Source: Novartis cedure. The first successful pan-European 8 switch was GlaxoSmithKline’s weight-loss transaction of 2010, Novartis’ acquisition Alcon is the worldwide leader in IOLs drug alli. The EMA cleared the switch of of Alcon occurred in various stages. An- based on the AcrySof family, which ex- pantoprazole to OTC status in June 2009, nounced on the fourth day of 2010, No- ceeded $1 billion in 2008 sales. Alcon’s one month after the Rx drug lost patent vartis agreed to purchase 52% of Alcon portfolio of specialty medicines covers protection in 12 European countries, ac- shares at a value of $28.3 billion. Having various eye diseases such as glaucoma cording to reports. already acquired 25% of Alcon during July and conditions in the front of the eye like Pantoprazole is the active chemical in 2008, Novartis as a result had attained 77% infections and allergies. Alcon also pro- the Rx blockbuster brand Protonix/Panto- majority ownership of the eye-care lead- vides a portfolio of contact-lens-care zol/Pantoloc. These brands are marketed er. Then during December 2010, Novartis products, OTC dry-eye drops and ocular worldwide by Nycomed and Pfizer Inc. obtained the remaining minority stake of vitamins. Emerging markets has been a (via its 2009 acquisition of Wyeth). 23% for $12.9 billion. Through the two trans- key growth driver for the company. Retail sales of Prevacid24HR have actions that combine for a value of $41.2 “The full merger is the logical conclu- spurred Novartis’ U.S. OTC business into billion (and a total of $51.6 billion when in- sion of our initial strategic investment in Al- the fastest-growing in its peer group. Pre- cluding the initial 25% deal in 2008), No- con,” stated Daniel Vasella, M.D., Novar- vacid24HR contains 15 milligrams of lanso- vartis becomes the premiere player in the tis chairman. “With this step Novartis takes prazole, which is the main chemical in worldwide eye-health arena. full ownership, becoming the global lead- the blockbuster Rx medicine Prevac- Novartis and Nestlé first entered into er in eye care, a rapidly expanding, in- id/Takepron (lansoprazole). Prevacid/ the 77% majority-stake deal during April novative platform based on the growing Takepron is marketed worldwide by Ja- 2008 as part of a two-phase process. The needs of an aging population.” pan’s Takeda Pharmaceutical Co. The total cost to Novartis for the 77% majori- According to Mr. Jimenez, “The growth non-prescription version treats frequent ty stake of Alcon was $38.7 billion, or $168 synergies here are significant, as Alcon will heartburn that for 24 hours. per share. During July 2008 and as the first be the eye-care development engine for During fourth-quarter 2010, Pre- phase, Novartis acquired a 25% stake in Al- our best-in-class research organization, vacid24HR became one of the world’s con for $10.4 billion. The $168 per share re- and will leverage the Novartis market- top 20 OTC brands and Novartis’ second- flects a 17% premium over $143.18, which access capabilities outside the U.S. I am leading OTC brand in the United States. was agreed by Novartis and Nestlé to be very pleased that we were able to come The company’s leading OTC product is Alcon’s market price during April 2008. to this agreement and will be able to pro- Excedrin. The Novartis brand established Based in Hunenberg, Switzerland, Alcon vide Alcon employees the full benefits of itself as a top four brand in its category is the largest and most profitable eye-care being part of the Novartis Group.” and as the No. 2 fastest-growing brand company with more than 15,500 employ- According to Novartis, the eye-care in- among its competitors during 2010. Con- ees in 75 countries. For 2009, the company dustry offers additional growth opportu- taining acetaminophen, aspirin and caf- had sales of $6.5 billion, operating income nities underpinned by the increasing un- feine, Excedrin treats pain due to head- of $2.3 billion, and net income of $2 billion. met needs of emerging markets and an aches, backaches, colds and arthritis. Alcon’s product range includes pharma- aging population. The Alcon and Novar- Novartis is acquiring some OTC eye- ceutical, surgical and consumer eye-care tis eye-care portfolios address a wide ar- care products via its acquisition of Al- products to treat diseases, disorders and ray of these unmet needs. The companies con. The most expensive healthcare M&A other conditions of the eye. have complementary pharma portfolios for diseases in the front and back areas of Novartis the eye as well as strong lens-care brands around the globe. Alcon is a worldwide leader in ophthalmic surgical products. Novartis possesses a broad contact lens portfolio and advanced eye-care technologies as well as an early-stage pipeline of innovative ophthalmic medicines. The merger is anticipated to be finalized during first-half 2011. Implementation is expected to take six months from the closing of the merger. Following the completed merger, Alcon will be the new eye- care division of Novartis. Pro-forma sales of the new division for 2009 totaled $8.7 billion. The business will include Ciba Vi- sion and ophthalmic medicines. A worldwide leader that generates more than three-fourths of its yearly sales from contact lenses, Ciba has been growing due in part to new product introduc- tions in the Air Optix family of monthly Source: Novartis silicone hydrogel lenses and the Dailies 9 portion of its business via subsidiaries in the Novartis OTC Overview United Kingdom, Ireland and Canada. For Novartis OTC is a world leader in offering products for treating and preventing 2008, Chattem recorded revenue of $455 common medical conditions and ailments to enhance people’s overall health million and had 488 employees. and well-being. The OTC business is carried out by various affiliated companies OTC and consumer brands are core in 50-plus countries. growth platforms identified in sanofi-aven- The OTC segment concentrates on a group of strategic global brands in tis’ broader strategy for generating sus- leading product categories that include treatments for cough/cold/respiratory tainable growth. Although the Group (Triaminic, Otrivin, TheraFlu/NeoCitran); pain relief (Excedrin, Voltaren); generated roughly EUR1.4 billion in glob- smoking cessation (Habitrol/Nicotinell); dermatology (Lamisil, Fenistil); and al OTC sales during 2009, a direct U.S. pres- gastrointestinal (Benefiber, Prevacid24HR, Pantoloc Control). ence had yet to be established for sanofi- Pantoloc Control (pantoprazole 20 mg) was introduced across 14 European markets during May 2010 after having been centrally approved in June 2009 aventis until the arrival of Chattem. by the EMA for treating frequent heartburn. Pantoloc Control is a strategic “The acquisition of Chattem will be addition to the Novartis OTC product portfolio. The company anticipates that a significant milestone in sanofi-aventis’ the brand will drive strong growth of Novartis’ OTC Digestive Health category. transformation strategy and will provide us with the ideal platform in the U.S. consum- Source: Novartis er healthcare market, which represents 25% of the current worldwide opportunity,” according to Christopher A. Vieh- range of disposable lenses. Ciba offers an pact created the world’s fifth-largest con- bacher, sanofi-aventis CEO, at the time array of lens-care products. sumer healthcare company in terms of of the acquisition announcement. “In ad- Novartis now is the clear-cut leading product revenue by joining the operations dition, we believe our ability to convert force in the eye-care segment. Bausch & of Chattem with sanofi-aventis’ strong in- prescription medicines to OTC products Lomb Inc. is regarded as the No. 2 play- ternational presence in the sector. will be enhanced by Chattem’s leading er in the worldwide eye-health market. Chattem has been a top marketer sales, marketing and distribution chan- Bausch & Lomb is committed to bringing and manufacturer of a broad portfolio nels. We have great respect for Chat- visionary ideas to eye health. The cor- of branded OTC healthcare products, tem’s world-class management team, poration’s core businesses include con- toiletries and dietary supplements. Chat- which has an excellent track record of tact lenses and lens-care products, oph- tem’s products target niche market seg- sales and earnings growth based on thalmic surgical devices and instruments, ments and are among the market leaders building strong brands. With the poten- as well as ophthalmic pharmaceuticals. in their respective categories across food, tial access to switch products such as Al- Founded during 1853, Bausch & Lomb is drug and mass merchandisers. Chattem legra, I believe this team will take Chat- based in Rochester, N.Y., and has 10,000- has regularly shown the ability to sustain tem to even higher levels.” plus employees. The company’s prod- regular growth in terms of sales and prof- “This transaction offers immediate and ucts are sold in more than 100 countries. it via the development of its own brands significant value for Chattem’s share- For more details about Bausch & Lomb, and the successful integration of ac- holders and important benefits to our please see page 18. quired products. The 130-year-old com- employees, customers and communi- pany’s well-known brands include Gold ty,” said Chattem CEO Zan Guerry at the sanofi-aventis Bond, Icy Hot, ACT, Cortizone-10, Selsun time of the acquisition. “I am excited to Blue and Unisom. Chattem carries out a work with the sanofi-aventis team to cap- A leading global pharma entity, sanofi- aventis generated 2010 sales of EUR30.38 billion. The company’s broad portfolio of pharma products covers Rx medicines, generics, consumer healthcare and animal health. Sanofi-aventis is a global leader in human vaccines. With a broad and balanced presence in traditional and emerging markets, sanofi-aventis has 102,000 employees in 100 countries. Sanofi-aventis became a significant force in the OTC arena upon its acquisition of Chattem Inc. This transaction was ranked as the ninth-largest M&A transaction of 2009 by PharmaLive editors. Near the end of December 2009, sanofi-aventis entered into a definitive deal to acquire 100% of the outstanding shares of Chattem in a cash tender of- Source: sanofi-aventis fer for $93.50 per share, or $1.9 billion. The 10 ture the significant growth opportunities Allegra provides fast, non-drowsy, 24-hour Sanofi-aventis made another OTC this combination creates, as highlighted relief of allergy symptoms: sneezing; runny company acquisition during 2010. On by the planned launch of Allegra. Chat- nose; itchy, watery eyes; and itchy nose Oct. 28 of that year, a deal was struck in tem will form the base of a new consum- or throat. The product has provided al- which Sanofi Pasteur, the vaccines divi- er healthcare business in the United States lergy sufferers with relief of symptoms for sion of sanofi-aventis, agreed to acquire for sanofi-aventis, and the headquarters, nearly 15 years. all outstanding shares of BMP Sunstone manufacturing and leadership team will “Leveraging our U.S. Consumer Health- Corp. for cash consideration of $10 per continue to be based in Chattanooga.” care platform to convert prescription share, or a total of $520.6 million on a ful- Mr. Guerry and Chattem’s senior-man- medicines to OTC products is a key growth ly diluted basis. The acquisition was struc- agement team agreed to lead sanofi- driver for sanofi-aventis to become a di- tured as a merger of BMP Sunstone, which aventis’ U.S. consumer health division versified healthcare company also in the as a result becomes a wholly owned sub- following the close of the transaction. United States,” says Hanspeter Spek, pres- sidiary of sanofi-aventis. Sanofi-aventis is dedicated to Chattem’s ident, Global Operations. “The approval The price per share represented a 30% current operations and entrepreneurial of Allegra for OTC use further validates our premium above the closing price of BMP spirit as it builds a sizeable presence in the vision to increase our presence in the U.S. Sunstone’s shares as of Oct. 27, 2010. U.S. consumer-healthcare sector. Sanofi- consumer healthcare market.” BMP’s board of directors unanimously ap- aventis has maintained both of Chattem’s Mr. Guerry says, “We’re pleased to pro- proved the deal. existing manufacturing facilities and con- vide U.S. consumer access to Allegra, the BMP generated sales of $147 million in tinued construction on a third. The corpo- No. 1 U.S.-prescribed allergy treatment, 2009. Almost 60% of those sales derived rate brand of Chattem remained intact. allowing allergy sufferers to conveniently from the consumer-healthcare segment, Editor’s note: For more details regard- obtain a safe and effective medication where BMP has had access to retailers, ing the top 10 M&A industry deals of without a prescription,” county hospitals and community clinics 2010, 2009 and other significant trans- The Allegra family of OTC products is in Tier III and Tier IV markets. In this area, actions throughout the healthcare are- available without a prescription for allergy BMP has established two of China’s most na, please visit PharmaLive.com/Spe- sufferers in drug, grocery, mass merchan- recognized brands: “Hao Wa Wa” (Good- cial_Reports (Mergers & Acquisitions, diser and club stores throughout Amer- Baby), which has been recognized as the Partnerships, & Collaborations Review ica. This includes Allegra 24-Hour and No. 1 pediatric Cough & Cold brand in and Outlook). 12-Hour Tablets for adults and children China, and “Kang Fu Te” (Confort), a hy- During December 2009, sanofi-aven- 12 years of age and older; Children’s Al- giene brand for women’s healthcare. tis management announced that the legra 12-Hour Tablets for 6 years of age Following the October 2010 estab- company would seek to convert the an- or older, and Liquid for use in 2 years of lishment of the joint-venture Hangzhou tihistamine Allegra (fexofenadine HCl) age and older; Children’s Allegra 12- Sanofi Minsheng Consumer Health- from a prescription drug to an OTC prod- Hour Orally Disintegrating Tablets for care Co. Ltd. in partnership with Minsh- uct. Upon Allegra’s conversion, Chat- use in 6 years of age and older; and Al- eng Pharmaceutical Co. Ltd., the acquisi- tem would assume responsibility for the legra-D 24-Hour and 12-Hour Allergy tion of BMP gives sanofi-aventis a leading brand as part of becoming the platform and Congestion Extended Release Tab- consumer-healthcare presence in China for sanofi-aventis’ U.S. OTC and consum- lets (with a decongestant) for use in chil- with a strong position in Vitamins & Min- er healthcare business. As a prescription dren 12 years of age and older. erals Supplements and Cough & Cold. medicine for allergies and other condi- The Chattem acquisition is part of a These are the two largest categories of tions, Allegra generated blockbuster sales strategy by sanofi-aventis to diversify, par- that market. throughout the last decade. ticularly into sectors with stable product “The acquisition of BMP Sunstone will The Chattem acquisition has provided revenue as the company will face patent not only leverage our consumer-health- sanofi-aventis with a new platform that expirations in the next few years, includ- care business in China, but will also bring enables the conversion of prescription ing the blockbuster brands Plavix and us unique access to new expanding dis- medicines to over-the-counter products. Avapro. For 2010, sanofi-aventis report- tribution channels which are expected to Allegra represents sanofi-aventis’ first Rx- ed sales of EUR6.9 billion for Plavix/Iscov- account for a third of the pharmaceutical to-OTC conversion. er and EUR2.06 billion for Avapro/Aprov- market in China in the coming years” Mr. During January 2011, FDA approved el/Karvea. Viehbacher stated. “This transaction rep- the Allegra family of allergy medication Sanofi-aventis’ transformation strategy resents another strategic move for sanofi- products for OTC use in adults and chil- was evident in the third quarter of 2009 aventis to reinforce its leadership position dren 2 years of age and older. Allegra-D, as the company reinforced platforms for in China.” which relieves nasal congestion and sinus growth and forged ahead with its poli- BMP CEO David (Xiao Ying) Gao said, pressure, was made available without a cy of R&D alliances and targeted acqui- “This transaction offers immediate and sig- prescription at the pharmacy counter for sitions. On Oct. 30, 2009, the Group an- nificant value for BMP Sunstone stockhold- use in adults and children 12 years of age nounced the signing of a deal to acquire ers and important benefits to our employ- and older. Allegra and Allegra-D were in- all shares of Laboratoire Oenobiol, the ees and customers. I am excited to work troduced during March 2011 in their origi- French leader in nutritional supplements with the sanofi-aventis team to capture nal Rx strengths without a prescription. for health and beauty. During 2008, Oen- the significant growth opportunities this More than 40 million American adults obiol reported turnover of EUR58 million, of new combination will create in the con- suffer from indoor and outdoor allergies. which 85% was generated in France. sumer-healthcare market in China.” 11 Consumer healthcare is one of the Sanofi-aventis was the first foreign phar- Sanofi-aventis’ Consumer Health Care core growth platforms pinpointed in ma company to debut offices in China. business generated 2010 sales of EUR2.22 sanofi-aventis’ strategy for attaining sus- Sanofi-aventis has become one of the billion, up 45.7% at constant exchange tainable growth. As of October 2010, fastest-growing healthcare companies in rates year over year. Growth was lead Sanofi-aventis was the No. 5 consumer- that vast country with 5,000 people in 200- by Emerging Markets, where net sales healthcare company worldwide, and it plus cities. From prevention to treatment, advanced 44.4% at constant exchange continues to expand its presence in this sanofi-aventis is uniquely set up to take on rates to EUR1.05 billion. These figures con- field via organic and external growth. public-health needs in China. Sanofi Pas- solidate the consumer-health products of With an estimated size of EUR12 billion teur is a leading vaccines there. Zentiva NV from April 2009, Oenobiol as in 2010, the consumer-healthcare mar- Sanofi-aventis as of October 2010 had of December 2009, Chattem as of Febru- ket in China represents the second larg- three manufacturing facilities in China: in ary 2010, and Nepentes SA from August est worldwide after No. 1 United States. Beijing, Hangzhou, and Shenzhen. Sanofi- 2010. On a constant structure basis and China’s consumer-healthcare market has aventis is constructing three new facilities, at constant exchange rates, the division grown at a CAGR of 11% since 2005. This each set to start commercial production recorded 2010 sales growth of 6.9%, driv- trend is expected to continue during the in 2012, to meet the growing demand of en by Emerging Markets. coming years, spurred by continued ur- the Chinese market. The company is en- On March 11, 2009, sanofi-aventis suc- banization and improvement of patients’ gaged in integrated R&D in China from cessfully completed its offer for the East- affordability, a rising trend of self-medica- drug target identification to late-stage ern European generic player Zentiva. As tion, and the development of pharmacy clinical development. Sanofi-aventis’ Chi- of Dec. 31, 2009, sanofi-aventis held about chains and expanded retail offerings of na R&D Center and Asia Pacific R&D Cen- 99.1% of Zentiva’s share capital. The to- consumer healthcare products. ter are located in Shanghai. tal purchase amount was EUR1.2 billion,

Sanofi-aventis Consumer Health Care

Consumer Health Care (CHC) is a core growth platform identified in sanofi-aventis’ broader strategy for achieving sustainable growth. In 2010, the business recorded CHC sales of EUR2.22 billion; nearly half of sanofi-aventis’ CHC sales were in emerging markets, 28% in Europe, and 14% in the United States. Organic growth in 2010 was supported by sanofi-aventis’ CHC portfolio, which provides the company with a strong presence in the analgesics, gastrointestinal, and cough & cold areas. • Doliprane consists of a range of paracetamol formulas to fight pain and fever. Due to a wide offering in terms of dosages (from 2.4% paracetamol suspension up to 1-g formulas) and pharmaceutical forms (suspension, tablets, powder, suppositories), Doliprane covers the needs of the patients from baby to elderly. Doliprane is sold primarily in France. In August 2010, DolipraneLib (500-mg paracetamol tablets) was launched in France in new easy-to-carry packaging. • Magne B6 is a product containing magnesium and vitamin B6, which was granted its first marketing authorization in France during 1970. The product has now been granted marketing authorizations in more than 40 countries. MagneB6 has various therapeutic indications from irritability, anxiety and sleep problems to female health issues like premenstrual syndrome or menopause discomfort. MagneB6 is available in tablets as well as vials of oral solution. • Enterogermina consist of 2 billion Bacillus clausii spores in a ready-to-drink oral suspension in vials of 5 ml and in capsules. Launched in liquid form during 1958 in Italy, the new 2 billion dosage was launched in 2001; the capsule form was introduced during 2006. Enterogermina is indicated in the prevention and the treatment of intestinal imbalance during acute or chronic intestinal disorders (from babies to adults). Enterogermina is sold primarily in Europe and has been enjoying strong growth in Latin America. • Essentiale is a herbal preparation for liver therapy. The product is made of highly purified essential phospholipids extracted from soybeans and contains a high percentage of phosphatidylcholine, a major constituent of cellular membrane. Essentiale is used to treat symptoms such as lack of appetite, sensation of pressure in the right epigastrium, toxico-nutritional liver damage, as well as hepatitis. Essentiale is mainly sold in Russia (37% growth) and some South East Asian countries. • Maalox is a well-established brand consisting of two antacids: aluminium hydroxide and magnesium hydroxide. The product is available in several pharmaceutical forms — tablets, suspension, and stick packs — to provide consumer choice. Maalox was first launched in France during 1972 and is present in 55 countries, including in Europe, Latin America, Russia and some Asian countries. • NoSpa contains drotaverine hydrochloride. The product is indicated in abdominal spastic pain such as intestinal spasm, menstrual pain, or vesical spasm. NoSpa is sold primarily in Russia and Eastern Europe. • Lactacyd consists of a range of liquid soaps for feminine hygiene. Lactacyd is sold mainly in Brazil (28% growth) as well as Asia. • Chattem’s U.S. products are mainly branded consumer healthcare products, toiletries and dietary supplements across niche market segments. Well known brands include Gold Bond, Icy Hot, ACT, Cortizone-10, Selsun Blue and Unisom. • In January 2011, FDA approved the Allegra family of allergy medication products for OTC use in adults and children 2 years of age and older. The Allegra family of OTC products are available in drug, grocery, mass merchandiser and club stores nationwide as of March 2011. This switch constitutes a key step in sanofi-aventis’ U.S. CHC growth strategy.

Source: sanofi-aventis

12 including acquisition-related costs. Fol- generated 2010 OTC sales of $401 million and portability. The spare pair is conve- lowing the buyout of the remaining non- for Merck. Including 2009 sales from Scher- nient for nights out, weddings, traveling controlling interests, sanofi-aventis held a ing-Plough, Claritin OTC produced $367 through airports, and other times when a 100% equity interest in Zentiva effective million during that year. long trek in heels is uncomfortable. As of Dec. 31, 2010. Sanofi-aventis previous- Claritin is the leading physician-recom- August 2010, Fast Flats was the only brand ly had a 24.9% interest in Zentiva, which mended and pediatrician-recommend- of portable flats available at most drug was accounted for as an associate by the ed non-drowsy OTC brand for allergies. and mass retailers in America. The flats equity method. The Claritin Rx-to-OTC switch during 2002 come in female sizes 5-6, 7-8, and 9-10. The August 2010 acquisition of a 100% was the largest such switch ever as well as Merck Consumer Care introduced Dr. equity interest in the Polish company Ne- the first for a non-drowsy antihistamine. Scholl’s Custom Fit Orthotic Centers dur- pentes for PLN 425 million (EUR106 million) Claritin offers powerful non-drowsy ing July 2010. These kiosks help people find was intended to diversify sanofi-aventis’ allergy relief for 12 hours or 24 hours in customized solutions for their tired, achy consumer health portfolio in Poland, and various forms, including Claritin Tablets; feet. The kiosks use revolutionary Foot- in Central and Eastern Europe generally. Claritin Liqui-Gels, an easy-to-swal- Mapping Technology to measure arch low liquid-filled capsule; as well as Clari- type and the areas where people put the Merck tin RediTabs tablets, a quickly dissolving most pressure on to recommend the most tablet for patients ages 6 years and old- appropriate Custom Fit Orthotic. Merck is a worldwide healthcare leader er. Claritin 12-Hour RediTabs tablets of- The FootMapping Technology was de- known as MSD outside the United States fer the flexibility to manage allergy symp- veloped by Dr. Scholl’s scientists and eval- and Canada. Through Rx medicines, vac- toms all day or night. uated in five clinical trials. The technology cines, biologic therapies, as well as con- Claritin-D is available behind-the- uses 2,000-plus pressure sensors to mea- sumer-care and animal-health products, counter in 12-hour or 24-hour extended- sure foot areas where the most pressure is the company has a presence in 140-plus release tablets. Claritin-D includes the applied, arch type and foot length. Based countries via 94,000 employees. In 2010, decongestant pseudoephedrine for pow- on these criteria, the technology recom- Merck generated sales of $46 billion and erful nasal congestion relief. mends the Dr. Scholl’s Custom Fit Orthotic GAAP net income of $861 million. Dr. Scholl’s is the leading brand of foot- that is best suited for one’s feet. They offer Merck’s Consumer Care sales totaled care products in the U.S., providing com- all-day relief of tired, achy feet and elimi- $1.3 billion in 2010. This performance re- fort to millions for more than a century. nate foot discomfort immediately. flects continued strong performance of The brand offers more than 120 footcare “Fifty percent of adults suffer from tired, various key brands such as Dr. Scholl’s products. According to Merck, Dr. Scholl’s achy feet, especially if they have jobs that and Coppertone. Consumer Care in- uses the latest podiatric medicine and re- keep them on their feet all day,” accord- cludes footcare and suncare consumer search to revolutionize the way Americans ing to Dr. Leslie Campbell, a podiatrist at products as well as OTC medicines. think of and care for their feet. the Plano Physician’s Group in Plano, Dr. Scholl’s and Coppertone came to Dr. Scholl’s For Her is the first full line Texas, and a consultant to the makers of Merck through the company’s 2009 ac- of footcare products designed specifical- Dr. Scholl’s. “A customized solution can quisition of Schering-Plough Corp. On ly for women. Products range from pedi- make a real difference in foot comfort, March 9 of that year, the two companies cure-related to heel insoles. and these revolutionary Dr. Scholl’s Cus- agreed to a reverse merger transaction Dr. Scholl’s For Her Fast Flats was tom Fit Orthotic Inserts are a great, afford- amounting to $41.1 billion. The acquisition launched in August 2010. The compact able way for people to relieve their tired, provided Merck with patent-protected and foldable shoes fit discreetly in a purse achy feet.” blockbusters and a strong product pipe- and come with a wristlet for easy storage The Coppertone line of products in- line. With Schering-Plough’s 18 Phase III projects, the new Merck became one of Merck Consumer Care the leading R&D players. Schering-Plough also provided Merck with a significant The Consumer Care segment of Merck develops, manufactures and markets consumer-products presence. OTC, foot-care and sun-care products. The segment’s main brands include: Merck’s Consumer Care business includes the company’s U.S. and Canada Over-the-Counter Products Claritin non-drowsy antihistamines; MiraLax treatment for occasional consumer-product sales. Consumer-prod- constipation; Coricidin HBP decongestant-free cold/flu medicine for people uct sales for the rest of the world under with high blood pressure; Afrin nasal decongestant spray; and Zegerid OTC MSD are included in the company’s Hu- treatment for frequent heartburn. man Health segment. For 2010, global Foot Care Human Health sales (which includes the Dr. Scholl’s foot-care products; Lotrimin topical antifungal products; and prescription-drug business) totaled $39.81 Tinactin topical antifungal products and foot & sneaker odor/wetness billion and Consumer Care sales amount- products. ed to $1.34 billion. Sun Care Merck’s leading consumer-care prod- Coppertone sun care lotions, sprays and dry oils; and Solarcaine sunburn-relief uct in 2010 was Claritin, which was ac- products. quired from the Schering-Plough transac- Source: Merck tion. The former prescription blockbuster 13 cludes sun-care lotions, sprays and dry justed and portfolio-adjusted increase marily markets OTC products. The Con- oils. The brand dates back to 1944. was 1.7%. The HealthCare subgroup is di- sumer Care division is a leading player The Coppertone Solar Research Cen- vided into the Pharmaceuticals and Con- in the nonprescription-drug market. The ter in Memphis, Tenn., is one of the larg- sumer Health segments. Consumer Care product range includes est corporate facilities for testing sun- Within the HealthCare business, Phar- the pain relievers Aspirin and Aleve as screen effectiveness and performance. maceuticals sales for 2010 rose 4.2% (Fx&p well as the dermatology products Canes- Suncare scientists carry out hundreds of adj. 0.9%) to EUR10.91 billion. Bayer’s Con- ten and Bepanthen/Bepanthol. Nutri- tests on sunscreen formulas at the cen- sumer Health Sales improved 8.8% (Fx&p tionals include Supradyn, One A Day, ter every year to ensure products meet adj. 3.4%) to EUR6.01 billion versus 2009, Berocca and Redoxon; antacids; and both consumers’ needs and rigorous test- with all regions – particularly North Amer- cough-and-cold products. ing standards. The R&D team oversees the ica – contributing to the growth. The Con- According to Bayer, its Consumer Care development of a many different global sumer Health segment consists of the division is the No. 2 OTC company world- suncare products that are manufactured Consumer Care, Medical Care and Ani- wide. Based in Morristown, N.J., Bayer and marketed worldwide, including in Eu- mal Health divisions. Consumer Care has operations in 140- rope and Japan. In the non-prescription medicines busi- plus countries. Formed in 1995, the division During April 2010, Zegerid OTC for treat- ness (Consumer Care), the pain reliever has benefitted from significant growth ing frequent heartburn became available Aleve recorded the highest 2010 sales and development of its Intendis prescrip- in drug stores, grocery stores, mass mer- growth at 18.7% (Fx adj.). The Bepanthen/ tion dermatology business. chandisers and club stores throughout Bepanthol line of skincare products addi- Intendis is an integrated pharma busi- America. FDA approved Zegerid during tionally performed very well, with sales up ness with headquarters located in Berlin, December 2009 for OTC use. Please see advancing 12% (Fx adj.). Business in Bay- Germany. As part of Bayer HealthCare, In- page 15 for more details. er’s Medical Care Division was hampered tendis is committed to dermatology. The by the negative trend in the U.S. diabetes- company is concentrated on the devel- Bayer care market (blood-glucose meters, etc.), opment and marketing of high-quality, where sales of the division declined 20.3 % innovative topical therapies targeted to Germany’s Bayer is a worldwide enter- (Fx adj.) due to price and volume reasons. treat skin disorders. Intendis’ product port- prise with core competencies in the areas On the other hand, the Animal Health Di- folio consists of treatments for eczema dis- of healthcare, nutrition and high-tech ma- vision “posted a very satisfactory trend, orders, including atopic dermatitis as well terials. The Bayer Group generated 2010 benefiting from a 14.6% (Fx adj.) increase as psoriasis, acne, rosacea, hemorrhoids sales of EUR35.09 billion, up 12.6% com- in sales of the Advantage line of flea, tick and fungal skin infections (mycoses). pared to 2009. The three primary business and worm control products that was driv- Although the Consumer Care division’s areas are HealthCare, CropScience, and en by gains in the United States.” sales and distribution channels outside Eu- MaterialScience. For 2011, Bayer anticipates for its Con- rope are generally supermarket chains, Bayer HealthCare AG is a research- sumer Health segment above-market drugstores and other large retailers, phar- er, developer, manufacturer and market- sales growth after adjusting for currency macies are the usual distribution channel er of innovative products for disease pre- and portfolio effects. Sales and EBITDA be- in Europe. vention, diagnosis and treatment. Sales fore special items are projected to rise by Bayer is considered one of the leading in 2010 for the HealthCare business grew mid-single-digit percentages. companies in the market for blood-glu- 5.8% to EUR16.91 billion. The currency-ad- Bayer’s Consumer Health segment pri- cose-monitoring devices. The company’s Medical Care division offers user-friendly Bayer’s Best-Selling Consumer Health Products blood-glucose-monitoring devices such 2010 2009 as the single-strip Contour system and Product E million E million % Change Fx adj. Change the multi-strip Breeze system. Bayer addi- Contour (Medical Care) 602 601 0.2 (4.5) tionally markets the Contour usb meter, Aspirin* (Consumer Care) 418 400 4.5 0.2 which features integrated diabetes-man- Advantage product line (Animal Health) 408 336 21.4 14.6 agement software and direct plug-in to Aleve/naproxen (Consumer Care) 273 217 25.8 18.7 computers, as well as the A1CNow system for determining long-term blood glu- Bepanthen/Bepanthol (Consumer Care) 212 186 14.0 12.0 cose control (A1c). Outside Europe, these Canesten (Consumer Care) 210 188 11.7 7.7 products are mainly sold to consumers via One A Day (Consumer Care) 178 153 16.3 10.0 pharmacies, drugstores, mass merchants, Baytril (Animal Health) 166 149 11.4 5.8 hospitals or wholesalers. In Europe, they Supradyn (Consumer Care) 138 136 1.5 0.7 are primarily sold through pharmacies. Breeze (Medical Care) 125 138 (9.4) (13.6) Within the Medical Care segment, Bay- Totals 2,730 2,504 9.0 4.2 er is the world’s leading supplier of con- Proportion of Consumer Health sales 45% 45% trast-agent injection systems for diagnostic and therapeutic medical procedures Notes: Fx adj. = currency-adjusted * Total Aspirin sales = E776 million (2009: E715 million), including Aspirin Cardio, which is reflected in sales of the in computed tomography, magnetic res- Pharmaceuticals segment. onance imaging and molecular imaging Source: Bayer as well as mechanical systems for remov- 14 ing thrombi from blood vessels. Bayer of- and chairman of Bayer’s HealthCare ex- ufactures, markets and distributes high- fers service products for these systems. ecutive committee. “I am confident that quality pharmaceuticals via two divisions. The products are marketed to cardiolo- she will continue to drive the exception- Par Pharmaceutical Inc. of Spring Valley, gists, radiologists and vascular surgeons al growth experienced under the leader- N.Y., is the generic drug division. Strativa in hospitals and out-patient clinical sites ship of Gary Balkema, who has made the Pharmaceuticals Inc. of Woodcliff Lake is via a worldwide direct sales organization decision to retire after 16 years with Bayer the proprietary products division. that is supplemented in some cases by lo- at the end of March.” On Sept. 24, 2010, Perrigo Co. an- cal distributors. nounced a filing an Abbreviated New The Animal Health division concen- Gastrointestinal disorders Drug Application (ANDA) with FDA for trates on the health of companion ani- omeprazole 20mg/sodium bicarbonate mals and livestock, for which bayer we One of the most competitive therapeu- 1,100mg. Also, the company provided pri- provides pharmaceuticals and groom- tic categories in the OTC product arena or notice of this filing toSchering-Plough ing products. The largest product line is is gastrointestinal disorders. In late March HealthCare Products Inc., a subsidiary of Advantix and Advantage for the pre- 2010, the OTC heartburn-treatment cat- Merck, and the Curators of the Universi- vention and treatment of flea infestation egory received another competitor: ty of Missouri, the listed patent owner. in dogs and cats, followed by Baytril for Zegerid OTC. Merck is the owner of the brand regula- the control of infectious diseases, Drontal The Merck drug was approved by FDA tory approval. and Drontal Plus wormers, and Baycox in December 2009 and provides a unique Four days earlier, Schering-Plough filed to treat pig coccidiosis. alternative for the 50-plus million Ameri- suit alleging patent infringement in the Bayer Animal Health has leading posi- cans suffering from frequent heartburn. U.S. District Court of New Jersey to pre- tions in individual countries and product Zegerid OTC is the only over-the-counter vent Perrigo from proceeding with the segments. Bayer is the world’s No. 4 ani- proton-pump inhibitor product with two commercialization of the product. This mal-health company based on sales. De- active ingredients. The patented dual-in- action formally started the process un- pending on local regulatory frameworks, gredient formulation joins together a pre- der the Hatch-Waxman Act. Santarus its animal-health products may be avail- scription-strength acid-reducing medicine and the Curators of the University of Mis- able to end users as prescribed by a vet- (omeprazole) and a secondary ingredi- souri, licensor and owner of the patents, erinarian or prescription-free from veteri- ent (sodium bicarbonate) that enables were joined in the lawsuits as co-plaintiffs. narians, pharmacies or retail stores. efficient absorption. In connection with litigation relating to In February 2011, Erica L. Mann was Zegerid OTC capsule is available as its Zegerid brand prescription products, the named president of Bayer Consumer original 20-mg prescription-strength ver- U.S. District Court for the District of Dela- Care. She additionally was appointed a sion. The prescription medicine has a sig- ware ruled during April 2010 that the same member of the Bayer HealthCare exec- nificant six-plus year track record with patents that are the subject of the afore- utive committee. Ms. Mann join the com- physicians. The Rx brand is marketed by mentioned action were invalid due to ob- pany effective March 14, 2011. She most Santarus Inc., which is losing revenue for viousness. An appeal of that decision was recently was president and general man- the product due to the availability of ge- filed during May 2010, and the appeal re- ager of Pfizer Nutritional Health, a world- neric versions. Par Pharmaceutical Com- portedly is pending. wide business unit with operations in 80- panies Inc. introduced a generic ver- Perrigo’s product is generically equiv- plus countries. sion of Zegerid Capsule during late June alent to Schering-Plough’s Zegerid OTC Ms. Mann joined Pfizer upon its acquisi- 2010. Other generic players have done (omeprazole 20 mg/sodium bicarbonate tion of Wyeth, where as senior VP of Nutri- the same, including privately-held, Cincin- 1,100mg) antacid indicated for the treat- tion she helped form the shape and stra- nati-based Prasco Laboratories. ment of frequent heartburn. Annual sales tegic direction of that new business unit. Santarus reported that net product for the OTC brand are estimated to be As managing director of Wyeth Australia sales for Zegerid brand prescription prod- about $60 million. & New Zealand, she launched a range ucts and sales of the authorized gener- “This filing is an example of our focus on of significant medicines and nutritionals. ic version of Zegerid Capsule totaled $11 bringing new Rx-to-OTC switch products Ms. Mann additionally steered Wyeth’s million in third-quarter 2010. In compari- to market,” said Joseph C. Papa, chair- Pharmaceutical business in South Africa son, net product sales were $31.5 million man and CEO of Perrigo. “It is a great ad- for more than a decade as managing di- for Zegerid brand prescription products dition to our diverse offering of gastroin- rector and CEO. She holds the distinction during July-September 2009. Before ge- testinal products.” of being the first female CEO of a phar- neric competition set in, yearly U.S. sales Perrigo is a top worldwide healthcare ma company in that country. of Zegerid capsule amounted to about supplier that develops, manufactures and “Over the past 25 years, Ms. Mann $195 million. distributes OTC and generic prescription has become noted in the industry for her San Diego-based Santarus is a special- pharmaceuticals, infant formulas, nutri- strong record of delivering business re- ty biopharma company concentrated on tional products, active pharmaceutical sults. Her outstanding experience and in- acquiring, developing and commercial- ingredients (API), as well as pharma and sights will drive Consumer Care to take izing proprietary products that address medical diagnostic products. Perrigo is advantage of the sustained growth fore- the needs of patients treated by physi- the world’s No. 1 store-brand manufac- cast for the OTC market,” according cian specialists. turer of OTC pharma products and infant to Dr. Jorg Reinhardt, chairman of Bay- Woodcliff Lake, N.J.-based Par Phar- formulas. The Allegan, Mich.-based com- er HealthCare’s board of management maceutical Companies develops, man- pany’s primary markets and locations of 15 Perrigo

Source: Perrigo manufacturing and logistics operations Zyrtec is not the only high-profile aller- “This is another example of Perrigo’s are the United States, Israel, Mexico, the gy OTC brand that has been targeted by strategic focus on making quality health- United Kingdom and Australia. Perrigo Perrigo. During June 2010, the company care more affordable to American con- reported sales of $1.36 billion for the six- acquired the exclusive U.S. store brand sumers by introducing new Rx-to-OTC month period ended Dec. 25, 2010, com- rights to sell and distribute OTC versions switch products,” Mr. Papa said. pared to $1.11 billion year over year. of Fexofenadine HCl 180 mg and 60- mg tabs, as well as Fexofenadine HCl 60 Other acquisitions Allergies mg and Pseudoephedrine 120 mg tabs. These products represent the generic ver- Perrigo announced on March 1, 2010, the Perrigo is an active competitor in the al- sions of sanofi-aventis SA’s Allegra and singing of a definitive deal to acquireOri - lergy OTC market. On July 26, 2010, the Allegra D-12 products. on Laboratories Pty. Ltd. for $48 million in company gained final U.S. approval to As of June 2010, the world’s leading cash. Located in Perth, Western Australia, manufacture and market OTC Cetirizine generic company Teva Pharmaceutical the privately held company is a leading Cherry Syrup, 1mg/ml. Shipments start- Industries Ltd. had Rx approval for these supplier of over-the-counter store-brand ed during Perrigo’s fiscal first-quarter 2011, products. Teva and sanofi-aventis, one of pharmaceuticals in Australia and New which ended Sept. 25, 2010. Cherry joined the top pharma players globally, have Zealand. Orion manufactures and distrib- Perrigo’s already-available grape flavor settled their Paragraph IV/Hatch-Wax- utes pharma products supplied to hospi- cetirizine syrup in its product portfolio, giv- man litigation. tals in Australia. The acquisition is expect- ing patients a choice of flavors. Allegra 180 mg, 60 mg, and Allegra ed to add $30-plus million in yearly sales The product is marketed under store- D-12 are indicated for relieving symptoms and be accretive to Perrigo’s earnings in brand labels and is comparable to McNeil associated with seasonal allergies. Sanofi- the first year. Consumer Healthcare’s Zyrtec Children’s aventis applied to FDA for the Rx-to-OTC “The acquisition of Orion expands our Allergy Syrup. That Pfizer brand is indicat- switch of these products. Before generic global presence, complements our exist- ed for indoor and outdoor allergy relief. competition entered the Fexofenadine Rx ing business and increases value for our Brand sales for the Zyrtec line of products, market during 2005, Allegra 180 mg and shareholders,” Mr. Papa commented. “By which includes cherry syrup, were report- 60 mg had joint yearly sales of $1.5 billion. leveraging Orion’s product pipeline and edly $580 million during the 52-week pe- For 2009, Allegra D-12 reportedly record- local marketing and distribution expertise, riod ended July 4, 2010. ed sales of $600 million. Perrigo is expanding its ability to meet the 16 world’s growing need for quality, afford- vice and directions on the label that do The medicine is then administered with able healthcare.” not match up exactly,” according to Dr. an accurately calibrated dosing spoon Perrigo additionally confirmed on Yin. in mL and ½ mL that is included in each March 1, 2010, that it closed the previ- Cornell University in early 2010 report- package. AccuDial offers parents a fool- ously announced sale of the Israeli Con- ed gross inadequacy of dosing with a proof method of minimizing dosing errors, sumer Products business to Emilia Group household spoon that conclusively leads with weight-specific dosing and a per- on Feb. 26th, 2010. The proceeds from this to overdosing and underdosing. These fectly matched dosing spoon. divestiture were used to fund the strate- finding came after FDA called for great- AccuDial is the industry leader in meet- gic acquisition of Orion. er consistency in dosing during Novem- ing the critical issue of inaccurate dosing ber 2009. of OTC children’s medications. “Mea- Dosing controversy AccuDial Pharmaceutical Inc., the suring dosages using a specific formu- maker of Children’s AccuDial pediat- la based on weight is standard practice During December 2010, controversial re- ric medications, during 2007 recognized among health care professionals such as sults were released from an NYU one-year that children were not being accurately doctors, nurses, and pharmacists,” stated research study on pediatric dosing instruc- dosed. The widespread amount of par- Bob Terwilliger, CEO of AccuDial, in De- tions on liquid medication. The findings ents that were unintentionally overdosing cember 2010. “Children’s AccuDial is a were revealed in the Journal of the Amer- and underdosing their children, and ar- game changer in the pharmaceutical in- ican Medical Association’s December is- riving at all hours at hospital emergency dustry with its line of eight children’s medi- sue. A comprehensive review of 200 of rooms across the country, was reaching cations, with weight-specific dosing, avail- the leading children’s liquid medications epidemic proportions. able in more than 4,000 pharmacies and found inconsistencies across all the med- As a result, AccuDial created a next- stores across Canada. AccuDial expects ications, with many having a problem. generation solution. The company devel- to have products available in U.S. phar- Under the direction of Dr. H. Shonna oped the only patented rotating weight- macies next year.” Yin, assistant professor of pediatrics at NYU based dosing system designed specifically AccuDial Pharmaceutical intends to School of Medicine, researchers found to properly calculate and administer chil- change the way liquid medications will that one-quarter of the OTC liquid med- dren’s pediatric liquid medications. The be dosed on a worldwide scale. AccuDi- ications do not contain a dosing device product’s dosing label dials in a child’s al is the only brand with a patented rotat- like a cup, dropper, or dosing spoon for weight in two-pound increments and ing weight-based dosing system designed administering medication. “We also found shows the correct weight-based dose in to administer OTC medications safely and that 99% had markings on the dosing de- milliliters (mL). effectively. OTC CompanIES Review This section of the report profiles in alphabetical order some of the world’s leading companies AS WELL AS UP- AND-COMERS IN THE OTC arena; some companies were already detailed on THE preceding pages of this report.

AccuDial Pharmaceutical Inc.

AccuDial was formed in 2007 for the pur- These products include pediatric medica- The company announced in March pose of commercializing patented pe- tions for pain & fever, allergy, and cough 2010 that its initial financing, a private diatric weight-based dosing products. & cold. The company anticipated that placement for 4 million shares at $1 per With headquarters in Palm Beach, Fla., Children’s AccuDial would be available share, successfully closed. the company markets and sells its prod- in 50% of Canadian pharmacies by the ucts in Canada, with plans to expand to end of March. AccuDial’s family of OTC the United States and Europe, products was approved by Health Can- quick facts AccuDial reported net revenue of ada in 2009. $125,324 for the fiscal year ended Sept. To oversee Canadian operations of 11300 U.S. Highway One 30, 2010, its first revenue since the com- AccuDial products, Christopher Vounasis Suite 202 pany’s inception in 2007. Product devel- was named director of Canadian Sales & Palm Beach Gardens, FL 33408 opment costs for 2010 totaled $462,170, Marketing in June 2010. Mr. Vounasis joins Phone: 561-429-6886 increasing from $160,969 in 2009. Net loss the company from PendoPharm, the Website: www.accuratedose.com increased from $1.9 million in 2009 to $5.8 OTC division of Pharmascience Inc., one Year established: 2007 million in 2010. The company recorded of the largest Canadian generic pharma net loss per share of 13 cents in 2010, com- manufacturers. His most recent position at Some Key Products: pared with net loss per share of 5 cents PendoPharm was national sales manag- AccuDial for children’s cough, cold in 2009. er, where he worked with retail outlets in and allergy symptoms AccuDial launched eight OTC prod- Canada and expanded the sales force ucts in Canada during January 2010. to achieve impressive growth. 17 Bausch & Lomb Inc. Xtra Hydration moisturizes and restores & Lomb Place address in New York. The Bausch & Lomb is a multi-national compa- the deficient aqueous and mucin layers company will remain in Rochester, where ny dedicated to bringing visionary ideas of the tear film to provide lasting comfort. it was founded 157 years ago. Bausch & to eye health. With headquarters in Roch- This eye product builds on the success of Lomb only occupies five of the 20 floors of ester, N.Y., Bausch & Lomb employs about the Soothe XP protection formula to of- the building. The building will be sold with 13,000 people and has products available fer patients a comprehensive OTC port- the assumption that Bausch & Lomb will in more than 100 countries. folio for dry eye. remain a tenant in its current space. The company markets a broad range Months after their launch though, Ideally, Bausch & Lomb will eventu- of products such as contact lenses, lens- Bausch & Lomb initiated a voluntary re- ally transfer its corporate offices to the care solutions as well as prescription and call for the Soothe Xtra Hydration drops company’s Optics Center, also located over-the-counter pharmaceuticals. beginning in January 2011. A small num- in Rochester. Bausch & Lomb’s OTC portfolio in- ber of consumer reports citing the pres- cludes Soothe and Soothe XP eye drops ence of possible foreign matter in the tips to treat and prevent dry eye, Ocuvite vi- of the bottles led to the recall. The com- tamins to promote eye health, and Renu pany recalled all lots of the product and quick facts brand contact lens solution. informed the FDA of this voluntary recall. In March 2010, Bausch & Lomb re- At the time of the recall, about 1.3 million One Bausch & Lomb Place launched Renu Fresh multi-purpose bottles had been distributed in the Unit- Rochester, NY 14604 contact solution. The solution comes in ed States. United States a clear bottle, allowing consumers to see In September 2010, Bausch & Lomb Phone: 585-338-6000 how much solution is remaining. announced it completed acquisition of Fax: 585-338-6007 Bausch & Lomb launched PreserVi- worldwide rights to assets and intellectu- Website: www.bausch.com sion Eye Vitamin and Mineral Supple- al property for Miochol-E from affiliates of Year established: 1853 ment based on the AREDS 2 formula in Novartis. Miochol-E is an injectable miotic No. of employees: 13,000 the United States in April 2010. The product pharmaceutical used during curtain eye supplements omega-3 fatty acids, lutein surgeries to constrict the pupil. In the ma- Some Key Consumer-Health and zeaxanthin, which studies show sup- jority of worldwide markets there are only Products: port eye health when included in a diet. two injectable miotics available, of which Soothe eye drops for dry eye The company announced the U.S. Miochol-E is one. Ocuvite for eye health launch of Soothe Xtra Hydration lubri- In June 2010, Bausch & Lomb began Renu contact solution cant eye drops on May 4, 2010. Soothe searching for a buyer for its One Bausch

Bayer AG

Bayer is a global enterprise with 108,700 sales increased 4.5% from 2009 to 4418 Bayer Consumer Health intends to employees working in the fields of health million for 2010. Aleve/naproxen sales in- continue to take advantage of external care, nutrition and high-tech materials. creased 25.8% to 4273 million. growth opportunities in the form of strate- With headquarters in Germany, Bayer In the Consumer Health segment for gically relevant acquisitions or in-licensing. aims to create value through innovation, 2011, Bayer anticipates above-market One such growth opportunity is provided growth and high earning power. growth in sales after adjusting for curren- by the exclusive licensing deal with Astra- Bayer experienced a 12.6% increase in cy and portfolio effects. Sales and EBITDA sales for 2010, coming in at 435.09 billion before special items are projected to in- compared with 431.17 billion for full-year crease by mid-single-digit percentages. quick facts 2009. Research and development expens- Bayer’s Consumer Health segment es also grew, increasing from 42.75 billion includes non-prescription medicines, 51368 Leverkusen for 2009 to 43.05 billion during 2010. Net dermatology products, blood-glucose Germany income for full-year 2010 came in at 41.31 meters, medical devices and its animal- Phone: +49 214 30 1 billion, versus 41.36 billion in the 2009 peri- health business. The goal of the Consum- Website: www.bayer.com od. Earnings per share were 41.57 during er Care Division is to build on its position in Year established: 1863 2010, down from 41.70 year over year. the worldwide OTC medicines market. No. of employees: 108,700 Bayer’s consumer-health segment, The division’s strategy is intended to ful- which chiefly offers non-prescription OTC ly leverage the growth potential of proven Some Key OTC Products: products, generated total sales of 46.01 brands such as Aspirin. Bayer is pursuing Contour Meter for insulin monitoring billion for 2010, up from 45.52 billion dur- a clear course of expansion in fast-grow- Aspirin for pain relief ing 2009. The company’s best selling OTC ing regions such as central and eastern Aleve for pain relief products include the Contour Meter, Aspi- Europe and Asia/Pacific. The company rin and Aleve. Contour sales totaled 4602 plans to additionally bolster its business in million in 2010, up 0.2% from 2009. Aspirin areas with growth potential. 18 Zeneca Plc. for the marketing of omepra- Arthur Higgins, was previously chief oper- learned more about Bayer than some zole under the Losec Pro, Antra or Mo- ating officer at Novartis AG. people do in 25 years with the compa- pralpro trademarks as a nonprescription On October 1, 2010, Werner Wenning ny.” medication to treat heartburn. This prod- handed over the chairmanship of the Gary Balkema, head of the Consum- uct has been introduced in seven mar- Bayer AG board to Dr. Marjin Dekkers. Mr. er Care Division, retired in March 2011. His kets as of early 2011, and launches are Wenning stepped down after 45 years of successor is Erica L. Mann. Ms. Mann most planned in additional countries. service with Bayer. recently served as president and gener- Bayer underwent a management Commenting on his successor, Mr. Wen- al manager of Pfizer Nutritional Health, a change in April 2010 when Dr. Jörg Re- ning said, “He is the right man in the right worldwide business unit with operations in inhardt was appointed CEO of Bayer place at the right time. In these last nine 80-plus countries. She was also a member HealthCare. Dr. Reinhardt, who replaced months Mr.. Dekkers, you have seen and of the Pfizer Senior Management Team.

Beiersdorf AG

Beiersdorf is a leading international skin sumed the role of chief information offi- nancial details of the transaction were not and beauty-care company. Since its cer of Beiersdorf. She succeeded Dr. Ernst disclosed. This move is in line with Beiers- founding in 1882, Beiersdorf continually Gadermann in the position, who retired in dorf’s “Focus on Skin Care. Closer to Mar- works to further strengthen consumer trust March 2010. kets.” strategy, which puts the focus on a in its brands with more than 20,000 dedi- Effective May 1, 2010, the executive small number of global skin-care brands. cated employees, outstanding research board of Beiersdorf was reorganized into “Selling the two brands will allow Beiers- and development activities, and innova- three functional and three regional areas dorf to focus its resources within the se- tive products. of responsibility. Thomas-B. Quaas remains lective market on developing La Prairie, The company’s total sales grew in 2010 chairman of the executive board, with Pi- the global premium skin-care brand,” said to 46.19 billion compared with 45.75 bil- eter Nota continuing to be responsible for Thomas-B. Quaas, chairman of the exec- lion for 2009. Global sales of Nivea, the Marketing and Innovation. Dr. Bernhard utive board of Beiersdorf. company’s largest brand, recorded or- Düttmann remains in charge of finance ganic growth of 1.8% for 2010. The brands as well as taking on the Human Resourc- La Prairie and Eucerin recorded growth es portfolio. Markus Pinger takes charge quick facts of 7.5% and 5.9%, respectively. of the Americas region as well as continu- Research and development expenses ing in charge of the global supply chain. Unnastraße 48 for 2010 were 4152 million compared with James C. Wei is heading up the Asia re- D-20245 Hamburg 4149 million in 2009. Net profit for 2010 to- gion, with Peter Feld named for the Eu- Germany taled 4326 million, down from 4380 million rope region. Phone: +49 40 4909 0 during the year before. Earnings per share Beiersdorf expanded its global pres- Fax: +49 40 4909 3434 for 2010 also decreased, totaling 41.40 in ence by establishing Beiersdorf Vietnam Website: www.beiersdorf.com 2010 compared with 41.65 in 2009. Limited in November 2010. With this affil- Year established: 1882 For 2001, Beiersdorf will invest heavily in iate, Beiersdorf has laid the groundwork No. of employees: 20,525 its skin and body-care brands. 2011 will be for further growth in Southeast Asia and another year of transition in which Beiers- meeting the rising demand for skin care Some Key Products: dorf will systematically implement its up- in Vietnam. Nivea dated strategy in the company and on In December 2010, Beiersdorf sold its La Prairie the markets using its package of invest- selective skin-care brand Juvena and its Eucerin ments and measures. premium hair-care brand Marlies Möller On April 1, 2010, Barbara Saunier as- to Troll Cosmetics GmbH in Austria. Fi-

Boehringer Ingelheim GmbH

Boehringer Ingelheim is a global group of come for 2009 totaled 41.8 billion ($2.5 er-care segment concentrates on nine companies with over 41,000 employees billion), increasing from 41.4 billion ($2 bil- core brands including Antistax, Binsol- operating in two main business areas: Hu- lion) in 2008. Research and development von, Dulcolax and Zantac. man Pharmaceuticals and Animal Health. costs were 42.2 billion ($3.1 billion) in 2009 In February 2010, Boehringer an- The Human Pharmaceuticals segment compared with 42.1 billion ($2.9 billion) in nounced its intention to acquire all out- is further broken down into Prescription 2008. standing shares in SSP Co. Ltd., a Japa- Medicines, Consumer Health Care, Biop- Boehringer’s Consumer Health Busi- nese subsidiary. A tender offer was issued harmaceuticals and Operations. ness is a core business segment, contrib- by Boehringer Ingelheim Japan In- The company reported net sales of uting 10% to total net sales. In 2009, the vestment GK (BIJI), a newly established 412.7 billion ($17.7 billion) in 2009, up from self-medication business had net sales Japanese company established for this 411.6 billion ($16.2 billion) in 2008. Net in- of 41.3 billion ($1.8 billion). The consum- purpose. As of April 13, 2010, 93.8% of out- 19 standing shares were tendered for total directors and responsible for the corpo- Also in January 2011, Boehringer an- consideration of 4611 million. SSP can ex- rate board division Pharma Research, De- nounced an agreement under which the pect benefits in new product develop- velopment and Medicine. “We remain company will acquire the rights in substan- ment. Boehringer will be able to enhance convinced of the positive benefit-risk ra- tially all assets at Amgen’s development its global Consumer Health Care business tio of flibanserin for women suffering with and manufacturing facility in Fremont, by sharing knowledge on Japanese con- HSDD.” Calif. The agreement was expected to sumers, skills and know-how on marketing In early 2011, Boehringer and Eli Lil- close in March 2011. and relationship management. ly and Co. announced an agreement The Fremont facility is a state-of-the-art Boehringer inaugurated “module 2” of to jointly develop and commercialize a 100,000-square-foot manufacturing facil- its new inhaler factory in September 2010. portfolio of diabetes compounds. Under ity with pilot plant and process develop- The new 12,000-square-meter building the terms of the agreement, Lilly will make ment labs. The site currently has about 360 doubles the company’s production ca- an initial one-time payment to Boehring- employees. pacity for Respimat inhalation devices to er Ingelheim of 4300 million. Boehringer In- 20 million. The Respimat Soft Inhaler is a gelheim is eligible to receive up to a total highly efficient device that delivers med- of 4625 million in success-based regulatory ication for the treatment of respiratory dis- milestones for linagliptin and BI10773. Lil- eases. In 2010, Respimat was launched ly is eligible to receive up to a total of $650 in 20 countries with a pharmaceutical for million in success-based regulatory mile- quick facts the treatment of chronic obstructive pul- stones on its two basal insulin analogues. monary disease. Should Boehringer Ingelheim elect to opt- Binger Strasse 173 The development of the investigational in to the Phase III development and po- 55216 Ingelheim am Rhein compound flibanserin was discontinued tential commercialization of the anti-TGF- Germany in October 2010. The company continues beta monoclonal antibody, Lilly would be Phone: +49 6132 77 0 to believe in the value of the product, eligible for up to $525 million in opt-in and Fax: +49 6132 72 0 which was intended for the treatment of success-based regulatory milestone pay- Website: Hypoactive Sexual Desire Disorder (HSDD). ments. The companies will share continu- www.boehringer-ingelheim.com The response of authorities as well as the ing development costs equally. Year established: 1885 complexity and extent of further questions Upon successful regulatory approval No. of employees: 41,534 to be addressed to achieve registration of of any product resulting from the alliance, flibanserin impacted the company’s deci- the companies will equally share in the Key Consumer-Health Products: sion to focus on other pipeline products. product’s commercialization costs and Antistax for leg health issues “The decision was not made lightly, gross margin. Each company will also be Binsolvon for cough symptoms considering the advanced stage of de- entitled to potential performance pay- Dulcolax for intestinal irregularity velopment,” said Professor Andreas Barn- ments on sales of the molecules they con- Zantac for heartburn er, chairman of the board of managing tribute to the collaboration.

C.B. Fleet Co.

Since 1869, C.B. Fleet has spread its reach well as potential acquisitions of businesses Home Depot. Total billings for the agency around the globe, never forgetting its her- in strategically important markets.” in 2009 amounted to $1.28 billion. itage as a hometown family-run business. In March 2010, Fleet launched Fleet The company offers products in feminine Naturals Cleansing Enema, the first en- care, gastro care, skin care, oral rehydra- ema designed for elective cleansing for tion, and oral care. men and women. Fleet Naturals is clinical- Fleet named Jeffrey Rowan as its new ly tested and doctor recommended. The president and CEO. Mr. Rowan previous- product is drug free and fragrance free. quick facts ly served as Fleet’s chief operating officer. On August 24, 2010, Fleet selected Dal- He succeeded Douglas Bellaire, who led las-based The Richards Group as the 4615 Murray Place the company from 1996. Mr. Bellaire now company’s agency of record. The Rich- Lynchburg, VA 24502 serves as the vice chairman of the com- ards Group is responsible for brand plan- United States pany’s board of directors. ning, creative development, digital de- Phone: 434-528-4000 “I’m very optimistic about the future sign, public relations, and media buying Website: www.cbfleet.com of Fleet Laboratories,” according to Mr. and planning for Fleets Summer’s Eve Year Established: 1869 Rowan. “We’ve been placing focus on brand of feminine-care products and improving organizational efficiency and gastro-care products. Key Products: strategic alignment, in preparation for our The Richards Group is the largest in- Fleet Laxatives for constipation next phase of expansion in the U.S. and dependent branding agency in the Unit- Clinomyn Toothpaste for oral care abroad. We anticipate growth will come ed States. Its clients include Amstel Light, Vera Lotion for skin care from both our existing brand portfolio, as Bridgestone, Chick-fil-A, Firestone, and The 20 Cardium Therapeutics Inc.

Cardium Therapeutics is a medical-tech- ber 2010 for the formulation, manufacture onstration of its ability to regain compli- nology company focused primarily on the and licensing of up to 20 advanced skin ance. The company received a letter on development and commercialization of care formulations and other products for July 7, 2010, stating that it had resolved all medical devices and novel therapeutics Cardium’s MedPodium line. Under the matters relating to Cardium’s exchange for cardiovascular and ischemic disease, agreement, Cardium is identifying a line of listing compliance. wound healing and tissue repair. The com- products applying BioZone technology in- Cardium launched Linee, a dietary pany’s innovative pipeline is divided into corporated into its QuSome, Inflacin, Lip- supplement used to manage weight loss, two units, Cardium Biologics and Tissue Ceutical, LipSpra and other formulation to its MedPodium line in November 2010. Repair Co. and delivery technologies. Cardium will The product is intended to be taken be- The company reported no revenue receive a royalty-free license for a port- fore meals to help manage appetite and for the nine-month period ended Sept. folio of 20 products selected by Cardium control hunger as part of a comprehen- 30, 2010. Research and development using BioZone technology. In exchange, sive weight management program. costs for the period totaled $1.9 billion, Cardium will pay $1 million through the is- dropping from $3.5 billion for the first nine suance of shares of its common stock. months of 2009. The company reported Early in 2010, Cardium received a let- a net loss of $5.2 million for the first three ter from the American Stock Exchange in- quarters of 2009, compared with a net loss dicating that the company had become quick facts of $21 million for the same 2009 period. noncompliant in regard to certain listing Loss per share for the first three quarters of requirements. The company was not de- 12255 El Camino Real 2010 totaled 7 cents, compared with 44 listed, but instead afforded an opportu- Suite 250 cents for the same time frame in 2009. nity to submit a supplement to the initial San Diego, CA 92130 In June 2010, Cardium and Devro Med- compliance plan in which Cardium Ther- United States ical Ltd. entered into a multi-year supply apeutics would establish its compliance Phone: 858-436-1000 agreement for highly-refined fibrillar bo- by June 2010. Fax: 858-436-1001 vine Type I collagen. Under the agree- In March 2010, Cardium announced Website: www.cardiumthx.com ment, the collagen component of Excel- that its listing compliance plan had been No. of employees: 13 legan will be manufactured at Devro’s accepted by NYSE AMEX LLC, formerly the new cGMP facility. American Stock Exchange. The exchange Some Key Products: Cardium and BioZone Laboratories then notified Cardium that, based on the Excellagen for tissue repair Inc. entered into a co-development and information provided by the company, MedPodium wellness products strategic licensing agreement in Novem- Cardium had made a reasonable dem-

Colgate-Palmolive Co.

Colgate-Palmolive seeks to deliver strong, gate Proclinical toothpaste in March lizing his 33 years of Colgate experience consistent business results by providing 2010. This toothpaste contains profes- and his proven capabilities as a financial consumers on a global basis with prod- sional formulas that allow consumers to leader.” ucts to make their lives healthier and more achieve a whiter smile with professionally enjoyable. The company focuses on Oral, inspired formulas from the comfort of their Personal and Home care as well as pet home. The product comes in three varia- nutrition, offering products in more than tions: Daily Whitening, Daily Cleaning and 200 countries. Daily Renewal. quick facts Colgate-Palmolive recorded net sales In December 2010, Stephen C. Patrick of $11.6 billion for the nine-month period stepped down as chief financial officer 300 Park Ave. ended Sept. 30, 2010, compared with after 14 years in the position. Dennis Hick- New York, NY 10022 $11.2 billion for the same period in 2009. ey, previously the company’s corporate United States Net income for the 2010 period was $1.6 controller, was appointed to the role of Phone: 212-310-2575 billion, a slight decrease from $1.7 billion CFO beginning on Jan. 1, 2011. Website: www.colgate.com in the first nine months of 2009. Earnings “Colgate has greatly benefited from Year established: 1993 per share dropped from $3.16 for the first Steve’s outstanding financial leader- No. of employees: 38,100 three quarters of 2009 to $3.07 in the 2010 ship,” commented CEO Ian Cook on the same time frame. change, “His strategic insights, keen fi- Some Key Products: Net sales in the Oral, Personal and nancial understanding and vast Colgate Colgate Orabase for canker-sore Home care segment were $10.1 billion knowledge have helped us advance our pain for January-September, up 4% from the key financial performance measures to Peroxyl Rinse for canker sores first three quarters of 2009. world-class levels. We look forward to Phos-Flur Rinse for cavity prevention Colgate-Palmolive introduced its Col- Dennis’ financial leadership as CFO, uti- 21 Galderma SA

Galderma is a 50:50 joint venture be- enhance the skin’s ability to restore hydra- days and an increase in the offer to SEK79 tween L’Oreal and Nestlé SA. Galderma tion and repair the epidermal barrier. per share. is focused on dermatological products for In January 2011, Galderma launched several skin conditions such as acne, ro- Emerval, a complete range of nine scien- sacea, psoriasis and melasma. The Swiss tifically advanced and clinically proven company distributes 11 major brands in hyaluronic acid dermal fillers. Commer- quick facts 70-plus countries. cialization of the product, indicated for Nestlé reported its 2010 Pharma sales the treatment of facial lines, contouring World Trade Center totaled CHF 6 billion. All Nestlé constitu- and volume loss, is scheduled for 2011 in Avenue de Gratta-Paille 1 ents, including Galderma, reportedly per- the United Kingdom, France, Germany, It- Lausanne, 1000 formed well in 2010. L’Oreal reported Gal- aly, Spain, Brazil and Argentina. Switzerland derma achieved record sales in 2010, with Galderma launched a bid for the Phone: +41 21 642 78 00 a like-for-like increase of 16.1% (and 23% Swedish company Q-Med in December Fax: +41 21 642 78 01 based on reported figures). 2010. Galderma believes the acquisition Website: www.galderma.com On Sept. 14, 2010, Galderma launched of Q-Med will enable the company to No. of employees: 3,000 Cetaphil Restoraderm, a product formu- accelerate its development in the highly lated specifically for the needs of eczema dynamic segment of corrective and aes- Some Key Products: and atopic dermatitis skin. Both Cetaphil thetic dermatology, which Q-Med spe- Benzac for the treatment of acne Restoraderm Skin Restoring Body Wash cializes in. As of Feb. 10, 2011, 77.79% of Nutraderm for dry skin and Skin Restoring Moisturizer soothe itch- Q-Med shareholders supported the deal, Cetaphil for skin care and protection ing associated with these diseases and leading to an extension on the offer of 15

GelStat Corp.

GelStat is a consumer-healthcare com- ficacy, safety and convenience. In line pany dedicated to cost-effective devel- with this strategy, two clinical studies have quick facts opment and marketing of OTC and oth- been carried out with GelStat Migraine, er non-prescription consumer healthcare each yielding positive results. 3557 SW Corporate Parkway products. The company markets GelStat The company reported net revenue of Palm City, FL 34990 Migraine and GelStat Sleep Aid. GelStat $35,181 for the nine-month period ended United States believes that its current and planned Sept. 30, 2010, compared with $41,532 for Phone: 772-283-0020 products will potentially offer consumers the same 2009 period. Net loss for the Jan- Fax: 772-219-3579 improved efficacy, safety and/or conve- uary-September 2010 period came in at Website: www.gelstatmigraine.com nience relative to existing products. $285,478 and the company reported a GelStat’s products have innovative for- loss per share of 0.01 cent. Key Products: mulations joined with uniquely advanta- Gelstat’s third product, GelStat Arthri- GelStat Migraine for migraine pain geous delivery systems. Thess combina- tis, is fully developed. The company ex- relief tions provide consumers with clinically pects the product to reach the market- GelStat Sleep Aid sleep supplement proven products that have improved ef- place during the first half of 2011.

GlaxoSmithKline Plc.

GlaxoSmithKline is an industry leader with billion in 2009 to $2.9 billion in 2010. Earnings tions as well as any suggestion that there an estimated 7% of the world’s pharma- per share also fell in 2010 to 49 cents from was a lack of publicly available clinical-tri- ceutical market. GSK, with headquarters $1.69 during the previous year. als results related to Avandia for indepen- in the United Kingdom and operations in GSK’s OTC products accounted for $3.8 dent scientific scrutiny. the United States, is one of the few phar- billion in sales during 2010, slightly increas- Both the U.S. and European regulatory maceutical companies researching med- ing from $3.6 billion in 2009. agencies conducted reviews of the bene- icines and vaccines for the World Health During 2010, GSK’s Avandia, indicated fit-risk profile of Avandia. As a result of these Organization’s three priority disease: HIV/ as an adjunct to diet and exercise to im- reviews, the European Medicines Agency AIDS, Tuberculosis and Malaria. prove glycemic control in adults with type suspended the marketing authorizations GSK’s sales for 2010 totaled $44 billion, 2 diabetes mellitus, came under scrutiny for Avandia and all related products con- down from $44.4 billion in 2009. Research in the United States and Europe. The drug taining its active ingredient rosiglitazone and development costs amounted to $6.9 was alleged to increase ischemic cardio- maleate. The EMA said this suspension will billion in 2010, compared with $6.4 billion vascular issues or cause myocardial isch- remain in place until convincing data is in 2009. Net profit for the year fell from $8.9 emic events. GSK rejected those allega- provided that identify a group of patients 22 in whom the benefits of the medicine out- the-counter use in key global markets. Europe and president designate, World- weigh its risks. Under the terms of the agreement, GSK wide Consumer Healthcare. Ms. Walms- In the United States, Avandia and all gained exclusive rights to commercialize ley replaced Manfred Scheske in Europe, rosiglitazone-containing products remain and distribute Xerclear as part of the Zovi- and will replace John Clark as president available with additional safety labelling rax franchise. The agreement includes Eu- of Worldwide Consumer Healthcare with- and restrictions for use. The FDA also re- rope, Russia, Japan, India, Australia and in two years. quires a Risk Evaluation and Mitigation New Zealand, and excludes North and Another succession plan was an- Strategy (REMS) program with addition- South America, China, South Korea and nounced in September 2010 to replace al measures to ensure the safe use of the Israel. Chief Financial Officer Julian Heslop, who medicine. GSK assumes responsibility for funding is retiring from the company at the end of In July 2010, GlaxoSmithKline finalized an continuing and future development of Xe- March 2011. Mr. Heslop will be replaced agreement for and Aptuit Inc. to acquire rclear in all included territories. GSK also by Simon Digemans, who was appointed operations at GSK’s Medicines Research is responsible for a $3 million up-front and chief financial officer designate in Janu- Center in Verona, Italy. Under the agree- pre-launch milestones and up to double- ary 2011. ment, Aptuit retains the facility’s 500-mem- digit royalties on sales to Medivir. ber staff, and gains their scientific exper- GSK acquired Nanjing MeiRui Phar- tise and knowledge. Financial terms of the ma Co. Ltd. (MeiRui) in December 2010. quick facts agreement were not disclosed. The company paid a cash consideration Another of GSK’s research centers was of $70 million. This move is intended to fur- 980 Great West Road acquired in September 2010, when Glaxo- ther expand GSK’s presence in China, one Brentford, Middlesex TW89GS SmithKline and Galapagos reached of the fastest-growing and most significant United Kingdom an agreement for a state-of the-art re- of the emerging markets. Phone: +44 208 047 5000 search center in Zagreb, Croatia. Under GlaxoSmithKline announced the ap- Fax: +44 208 047 7897 the agreement, Galapagos received the pointment of Philippe Fauchet as presi- Website: http://www.gsk.com center along with its 130 staff. Galapagos dent of GSK Japan in February 2010. Mr. Year established: 2000 will also provide GSK R&D services under a Fauchet previously worked at sanofi-aven- No. of employees: 13,500 three year fee-for-fee service contract to tis, where he served as senior VP of business the value of $14 million. development. Some Key OTC Products: In June 2010, GSK and Medivir an- In March 2010, GSK announced a suc- Tums for heartburn relief nounced an exclusive agreement to com- cession plan for the Consumer Healthcare Stanback for pain relief mercial the cold-sore treatment Xerclear division in which Emma Walmsley was ap- Abreva for cold sores (acyclovir and hydrocortisone) for over- pointed president of Consumer Healthcare

Hisamitsu Pharmaceutical Inc.

Founded in 1847, Hisamitsu is a leading ¥4.6 billion ($56.2 million) for the first three able for a single daily application. Since company in the field of drugs for external quarters of 2010. Feitas product sales Fentos has a clinical advantage of allow- use, actively seeking to enhance people’s dropped to ¥2.9 billion ($35.5 million), a de- ing easier adherence to the basic princi- health via the provision of pharma prod- crease of 8.4 %. Salonship product sales ples of opioid analgesics (“by the clock”) ucts, particularly pain-relieving patches. totaled ¥2.6 billion ($31.8million) and Bute- that require evaluation of pain and obser- The company reported sales of ¥102.6 na rock products totaled ¥1.1 billion ($13.5 vation of the presence of adverse reac- billion ($1.3 billion) for the nine-month pe- million), a decrease of 12.8% and 11.9%, tions every 24 hours, and scheduled ad- riod ended Oct. 31, 2010. This represents a respectively. Air Salonpas products post- 4.3% increase over the same period ended a positive gain in sales, increasing 7.8% ed in October 2009. Research and de- to ¥1.5 billion ($18.3 billion). quick facts velopment costs rose 48.2% to ¥9.5 billion Hisamitsu launched its Fentanyl Trans- ($116.2 million) for the nine-month peri- dermal System in the United States in 408 Tashireo Daikan-machi od ended in October 2010. The compa- March 2010. The product, which was ap- Saga, Tosu 841-0017 ny’s net profit for the first three quarters of proved by FDA in October 2009, is indicat- Japan the October 2010-ended period totaled ed for the management of chronic pain. Phone: +81 3 5293 1720 ¥16.7 billion. The product was launched by Apotex Fax: +81 3 5293 1724 Hisamitsu’s OTC business reported sales Corp., Hisamitsu’s exclusive distributor for Website: www.hisamitsu.co.jp of ¥14.2 billion ($204.2 million) for the first the product in the United States. Year established: 1847 three quarters of fiscal 2010, representing In April 2010, Hisamitsu received mar- No. of employees: 2,600 a decrease of 12.4 %. The company attri- keting approval of Fentos Tape, a trans- butes this decrease in sales to market re- dermal long-acting cancer-relief pain Some Key OTC Products: duction around the world. patch. The product is jointly marketed Salonpas for pain relief Several OTC products saw a decrease with Kyowa Hakko Kirin Co. Ltd. This Keplat Patch for pain relief in sales. Salonpas sales dropped 9.5% to patch has drug-release properties suit- 23 ministration at a predetermined time of its stock delisted from the Osaka Stock Ex- plication. It expects the delisting to have the day, it is expected to exert stable and change. The company cited the small vol- no effect on shareholders. Hisamitsu con- sustained analgesic effects. ume of stock being traded on the Osaka tinues to trade on the Tokyo, Nagoya and In May 2010, Hisamitsu applied to have Stock Exchange as the reason for the ap- Fukuoka Stock Exchanges.

Johnson & Johnson

Johnson & Johnson is a manufacturer of and Puerto Rico was recalled during Oc- care completed its internal assessment healthcare products as well as a provider tober 2010. of its manufacturing standards and proof related services for the consumer, phar- As a result of the recalls, McNeil an- cesses. The assessment was part of a maceutical, medical devices, and diag- nounced in June 2010 that it did not antic- commitment made by McNeil to restore nostics markets. J&J employs more than ipate having sources of supply before the its operations to the level of quality and 115,000 employees in consumer prod- end of the year at its Fort Washington, Pa., compliance expected by all Johnson & ucts, medical devices and diagnostics, manufacturing facility. Operations at the Johnson companies. McNeil thoroughly and prescription products. facility were suspended as a result of the reviewed historical records as far back The company reported sales of $61.59 recall, and the company has conduct- as 2007, investigating products sold in the billion for 2010, down 0.5% versus 2009. Re- ing a comprehensive quality assessment United States and produced in McNeil’s search expenses amounted to $6.84 bil- across its manufacturing operations. Mc- internal manufacturing network. McNeil lion during 2010, representing a 2% de- Neil identified corrective actions that will examined whether the right processes crease compared to 2009. Overall net be implemented before manufacturing had been identified and followed, and income for 2010 was $13.33 billion, increas- resumes at the Fort Washington plant. evaluated whether quality standards had ing 8.7% from the year-before amount. Dil- McNeil initiated another voluntary re- been met. luted earnings per share increased from call in April 2010, this time focusing on cer- McNeil identified several areas for im- $4.40 in 2009 to $4.78 in 2010. tain Children’s and infant’s liquid products provement, such as instances where J&J’s global Consumer sales totaled manufactured in the United States that equipment-cleaning procedures were in- $14.6 billion for 2010 represented – down are distributed in the United States, Cana- sufficient or cleaning was not adequate- 7.7% versus 2009 – consisting of an opera- da, Dominican Republic, UAE, Fiji, Guam, ly documented. McNeil also discovered tional 8.9% decrease and a positive cur- Guatemala, Jamaica, Puerto Rico, Pan- a product for which the labeling did not rency impact of 1.2%. Domestic sales in ama, Trinidad & Tobago and Kuwait. The all required information. 2010 dropped 19.3%. International sales recall was initiated because some of the “Steps we have taken under the Com- increased 1.2% versus 2009, reflecting an products may not meet quality standards. prehensive Action Plan constitute an un- operational 1% decrease and a 2.2% pos- Brands included in the recall are Tylenol compromising and systematic effort to itive currency impact. Infant Drops, Children’s Tylenol, Chil- review quality and manufacturing prac- In January 2010, J&J company McNeil- dren’s Motrin, Children’s Zyrtec and Chil- tices at McNeil,” Mr. Weldon said. “They PPC announced that its Consumer Health- dren’s Benadryl. help us assure that moving forward, any care Division was voluntarily recalling cer- In December 2010, McNeil initiated a of our products in the marketplace live tain OTC products in the Americas, the voluntary recall of all lots of Rolaids Ex- up to the trusted standards and expecta- United Arab Emirates, and Fiji. The recall tra Strength Softchews, Rolaids Extra tions that consumers have for all products came following an investigation of con- Strength plus Gas Softchews and Ro- coming from a Johnson & Johnson com- sumer reports of an unusual odor that was laids Multi-Symptom plus Anti-Gas Soft- pany, anywhere in the world.” associated with temporary and non-seri- chews. The recall was initiated following McNeil is additionally carrying out as- ous gastrointestinal events. These events consumer reports of foreign materials in include nausea, stomach pain, vomiting the products, such as metal and wood or diarrhea. Brands included in the recall particles. These particles may have been quick facts include Children’s Motrin, Motrin IB, var- introduced into the products during the ious strengths of Tylenol, Benadryl, Rolaids, manufacturing process at a third-party One Johnson & Johnson Plaza Simply Sleep and St. Joseph Aspirin. manufacturer. New Brunswick, NJ 08933 McNeil followed up this recall in June In January 2011, McNeil Consumer United States 2010 with a recall of five additional prod- Healthcare initiated a wholesale product Phone: 732-524-0400 uct lots. The involved lots included four recall of certain product lots produced Fax: 732-524-6735 product lots of Benadryl Allergy Ultratab at the Fort Washington facility before op- Website: www.jnj.com Tablets and one lot of Extra Strength Ty- erations were suspended. The recall is a Year established: 1887 lenol. These products were omitted from precautionary measure after a review of No. of employees: 115,500 the original recall. Another 21 more lots of the facility found instances where equip- medicines related to the January 2010 is- ment-cleaning procedures were insuf- Some Key OTC Products: sue of a moldy odor were recalled in July ficient or cleaning was not adequately Tylenol for pain relief 2010. documented. Mylanta for heartburn and indigestion An additional product lot of Tylenol 8 Following this last recall, J&J an- Benadryl for allergy symptoms hours caplets sold in the United States nounced that McNeil Consumer Health- 24 sessments at additional manufacturing lo- Dermatology. Cytomimic is a proprietary studies demonstrate improvement of the cations. technology that combines essential min- skin’s appearance starting within minutes During March 2010, Johnson & John- erals to deliver biological levels of elec- of application and continued improve- son Consumer Companies unveiled the tric signals similar to the skin’s natural bio- ments over time. Cytomimic Technology at the 68th annu- electricity. The technology is intended to al meeting of the American Academy of rejuvenate, repair and renew skin. Clinical

Matrixx Initiatives Inc.

Matrixx is a high-growth over-the-counter On Dec. 14, 2010, Matrixx entered into cept the offer, tender their shares in con- health-care company that markets and an agreement with Wonder Holdings nection with the offer, and approve and sells products with am emphasis on those Acquisition Corp. and Wonder Hold- adopt the merger agreement. that use unique and novel delivery sys- ings Inc., both affiliates of H.I.G. Capital In May 2010, Matrixx appointed Wil- tems. Matrixx sells products under the Zi- LLC. Under the merger, H.I.G.’s affiliates liam J. Barba as VP of finance and ac- cram brand through various subsidiaries. commenced a tender offer to purchase counting. Mr. Barba previously served as Net sales for the nine-month period for cash all of the outstanding shares of the company’s treasurer and director of ended Dec. 31, 2010. were $44.8 million, Matrixx common stock, including the as- plannin, since July 2007. a 27% decrease from $61 million for the sociated preferred stock purchase rights, same period in 2009. This decrease in sales at a price of $8.00 per share. Pursuant to is mainly attributable to the higher inven- the terms of the merger, Matrixx solicited tory positions retailers maintained associ- alternate acquisition proposals until Jan. quick facts ated with the H1N1 flu outbreak. Research 22, 2011. As of that date, despite inter- and development costs amounted to est from 132 parties, Matrixx received no 8515 E. Anderson Drive $1.2 million for April-December 2010, ver- other offers. As a result, Matrixx may not Scottsdale, AZ 85255 sus $1.9 million for the last three quarters encourage or solicit proposals from third United States of calendar-year 2009. Matrixx reported parties. Phone: 602-385-8888 a net loss of $8.4 million for the first nine On Feb. 2, 2011, the purchaser in- Website: www.matrixxinc.com months of its fiscal 2011, compared to a creased the price to $8.75 per share and Year established: 1991 net loss of $13.9 million for the same peri- extended the expiration of the offer until No. of employees: 29 od in fiscal 2011. Net loss per share totaled Feb. 14, 2011, at 11:59 p.m. The company’s 91 cents for the nine month period ended board of directors unanimously approved Some Key Products: Dec. 31, 2010, compared with a net loss the merger agreement and resolved to Zicam for cough and cold symptoms of $1.51 for the same 2009 period. recommend that Matrixx stockholders ac-

Merck & Co.

Merck is a global research-driven phar- $2.05 to $2.33. The 2011 non-GAAP EPS proved for over-the-counter use in 2009, maceutical company dedicated to put- range does not include purchase ac- is available in the original 20-mg prescrip- ting patients first. Established in 1891, Mer- counting adjustments, restructuring and tion strength formula. Zegerid OTC is a 14- ck discovers, develops, manufactures and merger-related costs. markets vaccines and medicines in more Merck’s Consumer Care sales rose than 20 therapeutic categories. from $149 million in 2009 to $1.3 billion in quick facts The company reported total sales of 2010, greatly benefitting form the Scher- $46 billion for 2010, increasing from $27.4 ing-Plough deal. Strong performances One Merck Drive billion in fiscal 2009. Research and de- came from key OTC brands, including the P.O. Box 100 velopment costs also increased, totaling Schering-Plough products Dr. Scholl’s and Whitehouse Station, NJ 08889 $10.9 billion in 2010 compared with $5.8 Coppertone. With Schering-Plough, Mer- United States billion in 2009. Earnings per share dropped ck’s revamped Consumer Care segment Phone: 908-423-1000 in 2010 to 28 cents, down from $5.65 in includes footcare and suncare consumer Website: www.matrixxinc.com 2010. The significant differences between products as well as various over-the-coun- Year established: 1891 2010 and 2009 are due to the Schering- ter medicines. No. of employees: 100,000 Plough acquisition. Merck announced on April 1, 2010, that Management expects full-year 2011 Zegerid OTC is available in drug stores, gro- Some Key OTC Products: revenue to grow in the low to mid-single cery stores, mass merchandisers and club Claritin for seasonal allergy symptoms digit percent range versus 2010. For 2011, shores nationwide. Zegerid OTC is a new Zegerid OTC for heartburn Merck is targeting full year non-GAAP EPS over-the-counter option for treating fre- Dr. Scholl’s for foot care and in the range of $3.64 to $3.76, excluding quent heart burn without the need for a pain relief certain items, and a GAAP EPS range of prescription. Zegerid OTC, originally ap- 25 day treatment course taken once a day to includes Afrin, Claritin, Coppertone, Dr. 2010. According to Merck, these chang- treat frequent heartburn as directed. Scholl’s and Lotrimin, among others. es are the result of a long-term, thought- In February 2010, Merck announced Merck announced additional se- ful succession planning process led by Mr. the appointment of Bridgette P. Heller as nior management appointments during Clark and the board of directors. executive VP and president of Merck’s April 2010. Kenneth C. Frazier was elect- Merck launched its Dr. Scholl’s Cus- consumer health business. Ms. Heller re- ed as president of Merck, moving from tom Fit Orthotic Centers nationwide in July placed Stanley F. Barshay who postponed his position as president of Global Human 2010. These kiosks use FootMapping Tech- his retirement to help with the Schering- Health. Adam H. Schechter replaced Mr. nology to measure arch type and recom- Plough transition period. Frazier as the president of Global Human mend the most appropriate Custom Fit As leader of Merck’s consumer health- Health. Orthotic. Dr. Scholl’s Custom Orthotics pro- care business, Ms. Heller is leveraging the Effective Jan. 1, 2011, Mr. Frazier also vide all-day relief of tired, achy feet, elim- company’s consumer products brands became CEO of Merck. He succeeded inating foot discomfort immediately. to capitalize on new growth opportuni- Richard T. Clark, who had served as CEO ties. This includes expanding the consum- since 2005 and continues as board chair- er business in markets outside the United man. Mr. Clark additionally was president States. Merck’s consumer health division of Merck before Mr. Frazier took over duing

Nycomed International Management GmbH

Nycomed is a privately owned global turing of Pantoprazole, Nycomed’s key tion agreement for the commercialization pharmaceutical company with head- product for acid-related gastrointestinal of Daxas in the U.K. quarters in Zurich, Switzerland, The compa- disease, makes the company one of the Under the terms of the agreement, Ny- ny has affiliates in more than 50 countries largest end-to-end manufacturers of that comed received an undisclosed up-front and employs 12,000 associates world- API in India. fee from Merck and is eligible for certain wide. The company ranks 28th among On November 1, 2010, Nycomed an- regulatory and commercial milestone pay- global pharmaceutical companies and nounced that it had acquired 51.34% of ments. The two companies co-promote the is the 16th largest provider of OTC prod- Guangdong Techpool Bio-Pharma Co. product in Germany, Italy Spain, Portugal ucts. Ltd. This move significantly expands its and Canada. Merck has exclusive rights to Nycomed reported net sales of 43.17 presence in China. Shanghai Pharma- the drug in the United Kingdom. billion for 2010, compared with 43.23 bil- ceutical Group holds 40.8% of the shares. Daxas received marketing authoriza- lion in 2009. Research and development As the majority owner, Nycomed plans to tion in the European Union on July 6, 2010. expenses for 2010 totaled 4212.2 million, fully consolidate the business moving for- The drug is indicated for the treatment of decreasing from 4198.6 million in 2009. The ward. Nycomed and Techpool will con- chronic-obstructive pulmonary disease, a company recorded a net loss of 4229.1 tinue to expand their footprint in China, life-threatening lung disease. million during 2010, compared with a net concentrating on five main brands: Uli- profit of4 232.7 million in 2009. nastatin, Kallikrein, Pantoloc, Ebrantil Net turnover for OTC in 2010 was 4372.9 and Actovegin. million, an 8.7% increase over 4343.2 mil- Nycomed expanded its presence in quick facts lion in 2009. This acceleration is driven Latin America during February 2011 by mainly by sustained double-digit growth acquiring Laboratorios Farmacol SA, a Thurgauerstrasse 130 in emerging markets, primarily Latin Amer- Colombia-based pharmaceutical com- 8152 Glattpark-Opfikon, Zurich ica and Russia, and strong performance pany. Farmacol has a strong presence in Switzerland of Nycomed’s OTC focus areas of gastro- the areas of gastroenterology, respirato- Phone: +41 44 555 10 00 enterology and respiratory. ry and gynecology. Nycomed expects Fax: +41 44 555 10 01 In September 2010, the joint venture Farmocal to provide access to the high- Website: www.nycomed.com company Zydus Nycomed (between growth (+14%) Columbian market, which Year Established: 1874 Zydus Cadila and Nycomed), commis- is Latin America’s fifth-largest pharmaceu- No. of employees: 12,000 sioned its pharmaceutical ingredient man- tical market. ufacturing facility at Navi Mumbai. India In April 2010, Nycomed and Merck en- Some Key OTC Products: The plant initially is manufacturing Panto- tered into a co-promotion agreement for Riopan for heartburn prazole, Urapidil and Lornoxicam. The Daxas (roflumilast) in Canada and cer- Ibumetin for pain relief company will be producing eight APIs at tain European countries. Additionally, the Calcium D3 for osteoporosis the plant by 2011. The plant’s manufac- companies signed an exclusive distribu-

Perrigo Co.

Established in 1887, Perrigo is a leading ops, manufactures and distributes over- pharmaceuticals, nutritional products, in- global healthcare supplier. Perrigo devel- the-counter and generic prescription fant formulas, active pharmaceutical in- 26 gredients, as well as pharm and medical ing Guaifenesin Extended-Release Tab- marketed under store-brand labels and is diagnostic products. Perrigo is the world’s lets 600mg, a generic version of Mucinex. comparable to McNeil Consumer Health- largest store-brand manufacturer of over- Adams Respiratory Therapeutics, hold- care’s Zyrtec Children’s Allergy syrup. The the-counter pharmaceutical products er of the New Drug Application and pat- Zyrtec brand reportedly recorded sales of and infant formula. Perrigo employs more ent, sued perrigo over the product. The $580 million for the 52-week period end- than 7,500 people worldwide, with prima- U.S. District Court for the Western District ed July 4, 2010. ry operations in the United States, Israel, of Michigan ruled that Perrigo does not in- Perrigo and Stiefel Research Austra- Mexico and the United Kingdom. fringe the patent in the suit. The Abbrevi- lia Pty. Ltd., a GlaxoSmithKline compa- The company reported net sales of ated New Drug Application for Perrigo’s ny, reached a settlement agreement on $1.4 billion for the six-month period ended product is awaiting FDA approval. Feb. 10, 2011, relating to Minoxidil foam. Dec. 25, 2010, compared with $1.1 billion In March 2010, Perrigo acquired Ori- Under terms of the settlement, Perrigo for the same time frame ended in 2009. on Laboratories for $48.6 million in cash. will be able to launch a generic version Research and development costs rose to Perrigo acquired about $600,000 of ac- of Men’s Rogaine Foam in the United a total of $42.3 million during the first half quisition costs, which were expensed in States on March 1, 2012, or earlier under of fiscal 2010 from $39.4 million in the first operations in the third quarter of fiscal certain circumstances. Men’s Rogaine, six months of fiscal 2009. Net income for 2010. Orion is a leading supplier of over- which is used to regrow hair on the top the first six months of fiscal 2010 totaled the-counter store-brand pharmaceutical of the scalp, has annual sales of rough- $164.5 million, compared with $112.7 mil- products in Australia and New Zealand, ly $60 million. lion during fiscal 2009. Diluted earnings per and manufactures and distributes phar- share rose from $1.21 in the first half of fis- maceutical products supplied to hospi- cal 2009 to $1.76 for the same period in tals in Australia. fiscal 2010. During May 2010, Perrigo acquired Perrigo’s Consumer Healthcare sales exclusive U.S. store brand rights from totaled $826.1 million for the first half of fis- Tris Pharma to sell and distribute Dex- quick facts cal 2010, up from $797.8 million in the first tromethorphan Polistirex Extended Re- half of fiscal 2009. The Consumer Health- lease Suspension Cough Suppressant, 515 Eastern Avenue care segment is the world’s largest store- the generic version of Delsym. The prod- Allegan, Michigan 49010 brand manufacturer of over-the-counter uct is indicated for 12-hour cough release, United States pharmaceutical products. Perrigo is the and has estimated annual sales of $125 Phone: 269-673-8451 market leader for consumer healthcare million. Website: www.perrigo.com products in many of the regions where In June 2010, Perrigo acquired exclu- No. of employees: 7,700 the company currently competes: the sive U.S. store brand rights to sell and dis- United States, United Kingdom and Mex- tribute generic Allegra (fexofenadine HCl Some Key OTC Products: ico. Store-brand private-label OTC prod- 180 mg and 60 mg) and Allegra-D12 (fex- Phenylephrine HCI Tablets for nasal ucts represent about 30% of the total retail ofenadine HCl 60 mg and pseudoephed- decongestion value of the categories in which Perrigo rine 120 mg) products Acetaminophen, Dextromethorphan competes. FDA granted Perrigo final approval to HBr, Doxylamine Succinate for Perrigo received a favorable ruling in manufacture and market OTC Cetirizine cold symptom relief February 2010 in patent litigation involv- Cherry Syrup in July 2010. The product is

Pfizer Inc.

Pfizer discovers, develops, manufactures, come decreased from $8.64 billion in 2009 Pfizer entered into various business and markets leading prescription medi- to $8.26 billion during 2010. Diluted earn- transactions during 2010, including a de- cines for humans and animals. The New ings per share also dropped between the finitive agreement to acquireKing Phar- York-based corporation also markets two years, decreasing from $1.23 in 2009 maceuticals Inc. as announced in Octo- many of the world’s best-known consum- to $1.02 in 2010. ber of that year. The announced purchase er products, including Advil, Dristan, Ro- Pfizer expects that it will lose exclusiv- price for King Pharmaceuticals is $3.6 bil- bitussin and Preparation H. ity for Lipitor in the United States in No- lion in cash, or $14.25 per share, without Revenue for Pfizer during 2010 totaled vember 2011, resulting in a substantial loss interest. During the first quarter of 2011, $67.81 billion, increasing 36% from $50.01 of its U.S. revenue from the product. Pfiz- King Pharmaceuticals became a wholly billion in 2009. This increase is due to the er granted Watson Laboratories Inc. an owned subsidiary of Pfizer and the com- inclusion of revenues from legacy Wyeth exclusive right to sell the generic version pany’s stock ceased trading on the NYSE. products of $18.1 billion, which favorably of Lipitor in the United States, which is ex- According to PharmaLive editors, this impacted revenue by 37%. Pfizer com- pected to begin in November. Pfizer will transaction was the ninth-largest among pleted its acquisition of Wyeth on Oct. manufacture and sell the product to Wat- healthcare M&A deals during 2010. 15, 2009. Research and development ex- son. Lipitor revenue in emerging markets During November 2010, Pfizer con- penses totaled $9.41 billion for 2010, com- should not be materially affected by the summated its partnership with Laborato- pared with $7.85 billion for 2009. Net in- loss of U.S. exclusivity. rio Teuto Brasileiro SA (Tueto), a Brazil- 27 ian generic company. Pfizer acquired a “Ferrosan is an excellent strategic fit that ed Ian C. Read as its new president and 40% equity stake in Teuto as well as two strengthens our presence in dietary supple- CEO on Dec. 5, 2010. Mr. Read previous- representatives on Teuto’s board of direc- ments with a new set of compelling brands ly served as the head of the company’s tors. Under terms of the agreement, Pfizer and product pipeline,” Mr. Sturman said. global biopharmaceutical operations made an up-front payment of $230 mil- Financial terms of the transaction, and succeeded Jeffrey B. Kindler, who lion. Teuto is eligible to receive a perfor- which is expected to close during the sec- retired from Pfizer. mance-based milestone payment from ond quarter of 2011, were not disclosed. Pfizer during 2012. Pfizer retains an option Coinciding with the 2010 holiday sea- to acquire the remaining 60% of the com- son, Pfizer launched Advil Congestion pany beginning in 2014. Relief in November 2010. The product In February 2011, Pfizer entered into a treats swelling due to nasal inflammation, quick facts definitive agreement to purchase Ferro- often the true cause of congestion. Advil san’s consumer healthcare business from Congestion Relief is a unique combination 235 East 42nd Street Altor 2003 Fund GP Ltd. The consumer of ibuprofen and phenylephrine that pro- New York, NY 10017 healthcare business includes dietary sup- vides relief from sinus pressure, nasal swell- United States plements and lifestyle products. ing and congestion, and headache. The Phone: 212-733-2323 Ferrosan is an innovative and long-es- product is sold at all major retailers nation- Fax: 212-733-7851 www.pfizer.com tablished consumer healthcare company wide in the United States. Website: Year established: 1849 based in Copenhagen, Denmark, with a Pfizer announced a voluntary recall No. of employees: 116,500 portfolio of leading brands. They include of one lot of ThermaCare HeatWraps in Multi-Tabs, a popular multivitamin; Bifi- September 2010. The recall is a precau- Some Key OTC Products: form, a leading probiotic; Fri Flyt/Active tionary step after the company found a Advil for pain relief Omega, an Omega 3 product; and Im- potential for a leak of the components Dristan Nasal Spray for nasal edeen, a premium oral skin-care brand. contained in the wrap, which could cause congestion due to allergies All of these products are among the top- skin injury such as irritation and burn. Robitussin cold symptom relief sellers in their respective categories. The Pfizer board of directors elect-

The Procter & Gamble Co.

Procter & Gamble’s business is focused egory by about half a point. P&G’s Per- States. The company stated that the re- on providing branded consumer goods. sonal Health Care volume grew in the low call was a precautionary step after find- The Cincinnati company’s products are single digits behind shipments of Vicks in ing that the product formulation may not sold in 180 countries through mass mer- developing regions, as well as increased meet the expiration date on the pack- chandisers, grocery stores, membership distribution of PuR in CEEMEA. This growth age. This recall was not a result of con- club stores, drug stores, and “high fre- was partially offset by lower shipments of sumer complaints. quency” stores. Prilosec OTC in North America. For the first six-month period ended In October 2010, P&G debuted Crest Dec. 31, 2010, the company reported net Pro-Health Complete Rinse with fluo- quick facts sales of $41.5 billion, compared with $40.8 ride for tooth care. The product re-builds billion for the same period ended in 2009. enamel, prevents cavities, cleans teeth One Proctor & Gamble Plaza Net earnings dropped from $4.7 billion in and gums, and freshens breath. Cincinnati, OH 45201 the first half of fiscal 2009 to $3.3 billion in P&G introduced a different Crest prod- United States the first half of fiscal 2010, Diluted earnings uct in March 2010: the Crest Pro-Health Phone: 513-983-1100 per share dropped as well, falling 26% to Sensitive Shield toothpaste. Crest Pro- Website: http://www.pg.com $1.11 in the first six months of fiscal 2010, Health is the only leading toothpaste to Year established: 1837 from $1.49 in first-half fiscal 2009. protect against teeth sensitivity as well No. of employees: 127,000 Net sales of P&G’s healthcare segment as cavities, gingivitis, tartar, plaque, fresh increased 1% to $6.12 billion for the six- breath and whitening. Some Key OTC Products: month period ended Dec. 31, 2010. This On June 24, 2010, P&G announced a Crest for dental care figure represented 14% of P&G’s total sales voluntary recall of its Vapospray 4-Hour Prilosec OTC for heartburn for that period. The company increased Decongestant Nasal Spray. The product Pepto-Bismol gastrointestinal relief global market share of its Oral Care cat- was distributed nationwide in the United

Reckitt Benckiser Plc.

Reckitt Benckiser (RB) manufactures and RB reported net revenue of £8.4 billion £7.8 billion ($12.2 billion). Net income for sells household and health-care products ($12.9 billion) for fiscal-year 2010, an 8% fiscal 2010 totaled £1.7 billion ($2.6 billion), in over 180 countries. increase from fiscal 2009 net revenue of compared with £1.4 billion ($2.1 billion) in 28 fiscal 2009. Diluted earnings per share rose International. RB made an initial offer for also has a personal-care business led by its from £1.95 ($3.01) in fiscal 2009 to £2.27 SSL at £11.63 per share. As of Nov. 3, 2010, hair gel and deodorant brand Set Wet. ($3.51) in 2010. RB had received 204,173,628 SSL shares, Commenting on the acquisition, Reckitt RB manufactures several market lead- representing 94.19% of the existing issued Benckiser CEO Bart Becht said, “The ac- ing products. Nurofen and Gaviscon are ordinary share capital of SSL. quisition of Paras is another step forward in leading analgesic and gastrointestinal SSL applied to the UK Listing Authority RB’s growth strategy in consumer health- brands in Europe and Australia. Stresils for the cancellation of the SSL shares on care. It creates a material healthcare in the No. 1 sore throat product globally. the official list and to the London Stock business in India, one of the most promis- Mucinex is the leading cough brand in Exchange for the cancellation of admis- ing healthcare markets in the world, with the United States. sion to trading of SSL shares on the LSE’s the addition of a number of strong and During the first half of 2011, RB intends main market. The delisting took place on leading brands.” to launch Nuromol, a new ibuprofen- Nov. 29, 2010. In November 2010, RB appointed Liz paracetamol combination tablet. The In December 2010, RB announced that Doherty as the company’s chief finan- company uses a patented manufactur- it agreed to buy the Indian company Pa- cial officer. Ms. Doherty previously served ing process so that the active ingredients ras Pharmaceuticals Ltd. for £460 million. a two-year stint as CFO of Brambles In- are released in a pre-determined way. Paras’ leading OTC portfolio includes dustries Plc., a top 25 company on the This process will result in superior, longer- Moov, the No. 2 topical analgesic pain Australian Stock Market. Ms. Doherty re- lasting pain relief. ointment in India; Krack, the No. 2 med- placed Colin Day, who left the compa- In July 2010, RB commenced an offer icated skin ointment for cracked heels; ny in January 2011. to acquire all outstanding shares of SSL and several other leading brands. Paras

Rohto Pharmaceutical Co.

Founded in 1899, Rohto is a Japanese- Rohto predicted that full-year fiscal based pharma company pledged to 2010 sales sould be strong in Japan due quick facts bring “Happy Surprises” through its prod- in part to a prediction of elevated pollen ucts and services. Rohto has more than levels in the spring. The company’s inter- 1-8-1, Tatsumi-nishi, Ikuno-ku 4,500 employees across the globe. national sales were expected to fall dur- Osaka 544-8666 The company reported net sales of ing the same time frame due to the global Japan ¥52.5 billion ($622.4 million) for the six- downturn and impact of exchange rates Phone: 81-6-6758-1231 month period ended Sept. 30, 2010, slight- from the rapid rise of the yen. Website: www.rohto.co.jp ly decreasing from ¥52.6 billion ($623.5 Sales of eye-care products dropped Year established: 1899 million) for the same period in 2009. Net in- 3.9% in the first six months of 2010 to ¥11.8 No. of employees: 4,617 come for the first half of fiscal 2010 totaled billion ($139.9 million). Skincare product ¥3.6 billion ($42.7 million), compared with sales for the same period totaled ¥30.9 Some Key OTC Products: ¥3.1 billion ($36.7 million) in first-half fiscal billion ($366.3 million), a 2.1% increase for Rohto V 11 for eye care 2009. Diluted net income per share rose the same period in 2009. Internal medi- Dryaid Ex for dry eye to ¥30.5 (36 cents) for the first six months cines totaled ¥7.5 billion ($88.9 million) for Alguard for hay fever of fiscal 2010 from ¥26.25 (31 cents) dur- the first half of fiscal 2010, decreasing from ing first-half fiscal 2009. ¥7.7 billion for the same 2009 period.

Sanofi-aventis (and Chattem) quick facts Sanofi-aventis has became one of the sanofi-aventis totaled 44.4 billion in 2010, leading players in the OTC arena through compared with 44.6 billion in 2009. Net in- Chattem Inc. 1715 West 28th St. its acquisition of the consumer-products come rose 6.8% to 49.2 billion in 2010, up Chattanooga, TN 37409 company Chattem. Sanofi-aventis re- from 48.6 billion in 2009. Earnings per share United States ported 2010 net sales of 430.4 billion, in- also grew in 2010, totalling 47.06 for the Phone: 423-821-4571 4 4 creasing 3.7% from 29.3 billion in 2009. year as opposed to 6.61 in 2009. Website: www.chattem.com The Chattem acquisition represented a Chattem was founded in 1879 in Chat- Year established: 1879 positive change of 4297 million in sales for tanooga, Tenn. The company has been No. of employees: 524 2010. As a whole, sanofi-aventis Consumer a leader in consumer health care, mar- Health Care sales totaled 42.2 billion, an keting brands such as Gold Bond, Allegra Some Key OTC Products: increase of 55% over 2009. Sanofi-aventis and IcyHot. Allegra for seasonal allergies attributes this increase to its acquisitions Chattem underwent a major change Gold Bond for irritated skin in this sector throughout the year, includ- when it was acquired by sanofi-aven- IcyHot for pain relief for pain relief ing Chattem. tis. The initial announcement came in Aspercreme Research and development costs for December 2009, with sanofi-aventis an- 29 nouncing it had entered into a definitive night Eastern time on Feb. 8, 2010. At the that FDA approved the Allegra (fexofena- agreement with Chattem to purchase the time, 18,611,072 shares of Chattem com- dine HCl) family of medicines for OTC use company for $93.50 per share, or approx- mon stock were tendered, representing in adults and children older than 2 years. imately $1.9 billion. 89.8% of shares on a fully diluted basis. U.S. consumers could purchase the prod- The commencement of the tender of- Sanofi-aventis wrapped up the acquisi- ucts without a prescription beginning in fer through sanofi-aventis’ wholly owned tion in March 2010, announcing it had ac- March 2011. Over 40 million American subsidiary River Acquisition Corp. took quired 100% of Chattem. Now Chattem adults suffer from indoor and outdoor al- place on Jan. 11, 2010. The offer obtained operates as a wholly owned subsidiary of lergies. The Allegra family of medicines, antitrust clearance on Jan. 26, 2010, when sanofi-aventis. The acquisition strength- which are indicated for the relief of symp- the waiting period under the Hart-Scott ened sanofi-aventis’ position in the U.S. toms associated with seasonal allergies, Rodino Antitrust Improvement Act of 1976 consumer market, which represents 25% are available in drug, grocery, mass mer- expired. of the world market. chandiser and clubstores across the Unit- The initial tender offer expired at mid- In January 2011, Chattem announced ed States.

Santen Pharmaceutical Co.

Santen specializes in the R&D, manufac- Inspire Pharmaceutical Inc. for certain in an effort to strengthen the compa- turing, and marketing of ophthalmic and ophthalmic uses. Diquas was launched in ny’s global product-supply capability. anti-rheumatic pharmaceuticals to pro- Japan during December 2010. The Osaka plant will be closed by March tect and improve people’s eyesight and In May 2010, Santen exercised its op- 2013, with the Shiga plant becoming a health. Santen was founded in 1890. tion to license Clinical Data Inc.’s high- core production site for Santen’s global Net sales for the nine-month period ly selective adenosine A2A agonist com- health supply, ended Dec. 31, 2010, totaled ¥82.1 bil- pound ATL313 for the development of lion ($985.1 million), decreasing 4.9% from topical treatments for certain ophthal- ¥86.3 billion ($1.04 billion) in the same pe- mic diseases, including glaucoma. Under quick facts riod for 2009. Net income decreased 9.6% terms of the agreement, Clinical Data was for the first three quarters of fiscal 2010 to paid $2 million up front, followed by devel- 9-19 Shimoshinjo 3-chome, ¥14.7 billion ($176.4 million). Net income opment, regulatory and commercial mile- Higashiyodogawa-ku per share for the same period totaled stone payments subject to the fulfillment Osaka 533-8651 ¥172.24 ($2.07). of certain conditions, as well as royalties Japan Santen’s OTC pharmaceutical product on product sales. In return, Santen re- Phone: 81-6-6321-7000 sales totaled ¥4.1 billion ($49.2 million) for ceived a worldwide license to ATL313 and Fax: 81-6-6321-8400 the first nine months of fiscal 2010, increas- an option for an additional compound for Website: www.santen.co.jp ing 0.7% from ¥3.6 billion ($43.2 million) in the development and commercialization Year established: 1890 the same period for 2009. of treatments for certain ophthalmic dis- No. of employees: 2,756 In April 2010, the Japanese Ministry of eases, including glaucoma. Health, Labour and Welfare granted ap- In September 2010, Santen announced Some Key OTC Products: proval for Diquas Ophthalmic Solution that it will transfer production and supply- Sante for eye care 3% (diquafosol tetrasodium) for the treat- chain management functions from its Diquas for dry eye ment of dry eye. Diquas was licensed from Osaka, Japan, plant to the Shiga plant

Taro Pharmaceutical Industries Ltd.

Taro is a research-based, international, earnings per share decreased from $2.99 approval from the U.S. FDA for its ANDA specialty-pharma company that devel- in 2009 to $1.27 in 2010. for Levetiracetam Tablets, 250 mg, 500 ops, manufactures and markets prescrip- In February 2010, Taro announced the mg, 750 mg and 1,000 mg. Levetiracetam tion and over-the-counter pharmaceu- discontinuation of manufacturing opera- Tablets, which are the bioequivalent to tical products. Established during 1950, tions at the sterile manufacturing facility Keppra Tablets, is a prescription product Taro’s research programs and niche strat- of its Irish subsidiary, Taro Pharmaceuti- indicated for the treatment of epilepsy. egy have enabled it to attain gross mar- cals Ireland Ltd., in Roscrea, Ireland. Taro The U.S. FDA approved Taro’s ANDA gins that are among the highest in the said it was no longer in the best interest of for Fluorouracil Topical Cream USP, specialty-pharma sector. the company to continue to incur losses 5% in March 2010. The bioequivalent of Taro’s net sales for 2010 were $392.7 from the facility or make the capital in- Valeant Pharmaceuticals International’s million, a 9.4% increase over 2009. Net in- vestments in order to achieve the level of Efudex, Fluorouracil Topical Cream USP is come decreased 56.8% to $52.4 million efficiency found at Taro’s other operating a prescription product used for the topi- in 2010, down from $121.3 million in 2010. facilities. The closure of the facility was ex- cal treatment of multiple actinic or solar R&D costs in 2010 totaled $36.2 million, in- pected to impact 30 employees. keratoses as well as superficial basal cell creasing from 34.4 million in 2009. Diluted Also in February 2010, Taro received carcinomas. 30 During June 2010, Granisetron Hydro- maceutical Industries Ltd. The agreement chloride Tablets USP, 1 mg, the bioequiv- facilitates the immediate transfer of the quick facts alent of Hoffman-La Roche’s Kytril, was families’ interest in Taro to Sun in accor- approved by U.S. regulators for the pre- dance with the previously agreed option 14 Hakitor Street, P.O. Box 10347 vention of nausea and vomiting associ- entered into by the parties in 2007. Sun Haifa Bay 26110 ated with chemotherapy and radiation and the board of directors of Taro con- Israel treatment. Granisetron tablets had U.S. currently entered into an agreement in Phone: 972-4-847-5700 sales of $15 million in 2009. which the current members of the board Website: www.taro.co.il The U.S. Patent and Trade Office issued resigned, and Sun appointees become Year established: 1950 patent 7,683,071 covering Taro’s T2007, directors of Taro effective immediately. No. of employees: 1,149 the sodium salt of diphenyl barbituric acid “We are gratified that the company’s (DPB). The patent is for one of a class of operational and financial turnaround Some Key Products: non-sedating barbiturate compounds leaves it on strong footing – and, we think, Amiodarone HCI for ventricular currently in development by the compa- with a bright future ahead,” said Barrie arrhythmias ny. Taro began Phase I testing on T2007 in Levitt, M.D., Taro chairman, on behalf of Clomipramine HCI for antidepression December 2009 for treating epilepsy. the company’s outgoing directors. “We Warfarin for anticoagulation Taro announced in September 2010 are proud of what we have achieved in that the Levitt and Moros families had Taro’s 60-year history, especially in the last nificant value that has been created for reached an agreement with Sun Phar- three years, and we take heart at the sig- our shareholders.

Unilever NV

Established during 1930, Unilever’s portfo- considered the world’s leading company lio includes more than 400 brands ranging in hair conditioning, second in shampoo, from nutritionally balanced foods to indul- and the third largest in styling. quick facts gent ice creams, affordable soaps, luxuri- Paul Polman, CEO of Unilever, said: Weena 455, PO Box 760 ous shampoos and everyday household “We are delighted to be acquiring Alber- 3000 DK Rotterdam care products. to Culver. Their people have done an ex- The Netherlands The company reported revenue of cellent job of building an impressive range Phone: +31 10 217 4000 $44.3 billion ($58.8 billion) for its fiscal-year of brands such as TRESemmé, VO5, Nexx- Fax: +31 10 217 4798 2010, increasing from $39.8 billion ($52.8 us, St. Ives and Simple. These will com- Website: www.unilever.com billion) in fiscal 2009. Net profit for fiscal plement Unilever’s existing portfolio of Year established: 1930 2010 was $4.6 billion ($6.1 billion), of which iconic brands like Dove, Clear and Sun- No. of employees: 107,000 $4.2 billion ($5.6 billion) was attributable to silk in hair care and Pond’s and Vase- shareholders of Unilever. This represented line in skin and will help build on our strong Some Key Products: an increase from $3.7 billion ($4.9 billion), global positions in both the hair care and Vaseline for skin care Sunsilk for hair care of which $3.4 billion ($4.5 billion) was at- skin care categories.” Dove for skin care and hygiene tributable to shareholders. During November 2010, Unilever con- Unilever’s diluted earnings per share tinued to strengthen the company’s per- rose from $1.17 ($1.55) in fiscal 2009 to sonal care segment through the acqui- the general counsel to the Unilever UK & $1.46 ($1.94) in 2010. Research and de- sition of the Sara Lee Personal Care Ireland business. velopment costs also rose in fiscal 2010, to- and European Laundry business. Under In March 2010, Unilever appointed taling $928 million ($1.2 billion) compared terms of the agreement, Unilever paid Keith Weed as chief marketing and com- with $891 million ($1.18 billion) in the pre- $1.2 billion in cash for Sarah Lee, whose munications officer. vious term. brands generated annual sales in excess Also in March, Vindi Banga left the po- Personal care sales, which include the of $750 million during the year ended in sition of president, Global Foods, Home sales of skin and hair-care products, de- June 2009. and Personal Care, after 33 years of ser- odorants and antiperspirants, as well as In September 2010, Unilever entered vice. Mr. Vanga was replaced by Dave oral care products, totaled $13.7 billion into an agreement to access and Apere Lewis, who previously served as executive ($18.1 billion) in fiscal 2010. This amount Life Sciences’ Digital Biology platform. VP of Unilever UK & Ireland. represented an increase from $11.8 bil- Terms of the transaction were not dis- lion ($15.7 billion) generated during fis- closed. The five-year initiative brings Uni- cal 2009. lever and Ampere scientists together to Unilever announced in September 2010 work on the core biology of aging. that it entered into a definitive agreement Unilever underwent several manage- to acquire U.S.-based Alberto Culver Co. ment changes during 2010. In February, for $3.7 billion. Alberto Culver shareholders Tonia Lovell was named Steve Williams’ voted in favor of the merger in December replacement as chief legal officer of the 2010. With this acquisition, Unilever is now company. Ms. Lovell previously served as 31 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 8/15/1950 CHLOR-TRIMETON CHLORPHENIRAMINE MALEATE TABLET, EXTENDED RELEASE; 12MG SCHERING-PLOUGH ORAL 10/18/1963 DRIXORAL DEXBROMPHENIRAMINE TABLET, EXTENDED RELEASE; 6MG;120MG SCHERING-PLOUGH MALEATE; PSEUDOEPHEDRINE ORAL SULFATE 10/18/1963 DISOPHROL DEXBROMPHENIRAMINE TABLET, EXTENDED RELEASE; 6MG;120MG SCHERING-PLOUGH MALEATE; PSEUDOEPHEDRINE ORAL SULFATE 11/7/1968 NEOPAP ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG POLYMEDICA 1/30/1974 MONISTAT 7 MICONAZOLE NITRATE CREAM; VAGINAL 2% JOHNSON AND JOHNSON 3/24/1976 GYNE-LOTRIMIN CLOTRIMAZOLE TABLET; VAGINAL 100MG SCHERING-PLOUGH 9/17/1976 HIBICLENS CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 4% REGENT 2/9/1978 ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG G AND W LABS 2/9/1978 ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG G AND W LABS 2/9/1978 ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 325MG G AND W LABS 10/18/1978 UNISOM DOXYLAMINE SUCCINATE TABLET; ORAL 25MG CHATTEM 11/8/1978 GYNE-LOTRIMIN CLOTRIMAZOLE CREAM; VAGINAL 1% SCHERING-PLOUGH 1/15/1979 MYCELEX CLOTRIMAZOLE Solution; Topical 1% BAYER HEALTHCARE 2/16/1979 MYCELEX-7 CLOTRIMAZOLE CREAM; VAGINAL 1% BAYER PHARMACEUTICALS 2/27/1979 MYCELEX-7 CLOTRIMAZOLE TABLET; VAGINAL 100MG BAYER PHARMACEUTICALS 4/22/1980 ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG ACTAVIS MID ATLANTIC 4/22/1980 ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 325MG ACTAVIS MID ATLANTIC 4/22/1980 ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG ACTAVIS MID ATLANTIC 4/22/1980 INFANTS’ FEVERALL ACETAMINOPHEN SUPPOSITORY; RECTAL 80MG ACTAVIS MID ATLANTIC 5/23/1980 HIBISTAT CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 0.5% REGENT 10/30/1980 AFRINOL PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE; 120MG SCHERING-PLOUGH ORAL 3/31/1981 CHLOR-TRIMETON CHLORPHENIRAMINE TABLET, EXTENDED RELEASE; 8MG;120MG SCHERING-PLOUGH MALEATE; PSEUDOEPHEDRINE ORAL SULFATE 3/15/1982 MONISTAT 7 MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG JOHNSON AND JOHNSON 10/8/1982 DELSYM DEXTROMETHORPHAN SUSPENSION, EXTENDED EQ 30MG HBR/5ML RECKITT BENCKISER POLISTIREX RELEASE; ORAL 10/14/1982 IOSAT POTASSIUM IODIDE TABLET; ORAL 130MG ANBEX 10/28/1982 HUMULIN R INSULIN RECOMBINANT INJECTABLE; INJECTION 100 UNITS/ML LILLY HUMAN 10/28/1982 HUMULIN R PEN INSULIN RECOMBINANT INJECTABLE; INJECTION 100 UNITS/ML LILLY HUMAN 10/28/1982 HUMULIN N INSULIN SUSP ISOPHANE INJECTABLE; INJECTION 100 UNITS/ML LILLY RECOMBINANT HUMAN 4/1/1983 TODAY NONOXYNOL-9 SPONGE; VAGINAL 1GM AZTIQ PHARMA 12/9/1983 GAVISCON ALUMINUM HYDROXIDE; TABLET, CHEWABLE; ORAL 80MG;20MG SANOFI-AVENTIS US MAGNESIUM TRISILICATE 12/9/1983 GAVISCON ALUMINUM HYDROXIDE; TABLET, CHEWABLE; ORAL 160MG;40MG SANOFI-AVENTIS US MAGNESIUM TRISILICATE 1/13/1984 NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE GLAXOSMITHKLINE 1/13/1984 NICORETTE (MINT) NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE GLAXOSMITHKLINE 1/13/1984 NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE GLAXOSMITHKLINE 5/18/1984 ADVIL IBUPROFEN TABLET; ORAL 200MG WYETH CONS 5/18/1984 MOTRIN IB IBUPROFEN TABLET; ORAL 200MG MCNEIL 5/18/1984 MOTRIN MIGRAINE PAIN IBUPROFEN TABLET; ORAL 200MG MCNEIL 5/23/1984 EPINEPHRINE EPINEPHRINE AEROSOL, METERED; 0.2MG/INH ARMSTRONG PHARMS INHALATION

Source: FDA.gov 32 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 12/24/1984 EXIDINE CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 4% XTTRIUM 12/24/1984 EXIDINE CHLORHEXIDINE GLUCONATE AEROSOL, METERED; 4% XTTRIUM TOPICAL 10/18/1985 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG PAR PHARM 11/29/1985 E-Z SCRUB 201 POVIDONE-IODINE SPONGE; TOPICAL 20% BECTON, DICKINSON 12/17/1985 EXIDINE CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 2% XTTRIUM 3/5/1986 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG WATSON LABS 5/30/1986 OCUCLEAR OXYMETAZOLINE SOLUTION/DROPS; 0.025% SCHERING-PLOUGH HYDROCHLORIDE OPHTHALMIC 7/15/1986 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG OHM 7/22/1986 CIDA-STAT CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 2% ECOLAB 7/22/1986 CHG SCRUB CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 4% ECOLAB 10/15/1986 PROFEN IBUPROFEN TABLET; ORAL 200MG CONTRACT PHARMACAL 12/1/1986 ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG PERRIGO NEW YORK 12/1/1986 IBUPROHM IBUPROFEN TABLET; ORAL 200MG OHM LABS 1/7/1987 E-Z SCRUB 241 POVIDONE-IODINE SPONGE; TOPICAL 10% BECTON, DICKINSON 2/17/1987 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG AMNEAL PHARMS NY 4/1/1987 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG VINTAGE PHARMS 4/6/1987 ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG PERRIGO NEW YORK 5/22/1987 DRIXORAL PLUS ACETAMINOPHEN; TABLET, EXTENDED RELEASE; 500MG;3MG;60MG SCHERING-PLOUGH DEXBROMPHENIRAMINE ORAL MALEATE; PSEUDOEPHEDRINE SULFATE 9/4/1987 FOAMCOAT ALUMINUM HYDROXIDE; TABLET, CHEWABLE; ORAL 80MG;20MG GUARDIAN DRUG MAGNESIUM TRISILICATE 9/10/1987 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG CONTRACT PHARMACAL 9/10/1987 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG CONTRACT PHARMACAL 10/2/1987 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG PAR PHARM 12/8/1987 TAB-PROFEN IBUPROFEN TABLET; ORAL 200MG PERRIGO 12/8/1987 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG PERRIGO 12/17/1987 BRIAN CARE CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 4% SOAPCO 2/2/1988 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG VINTAGE PHARMS 3/1/1988 IMODIUM A-D LOPERAMIDE SOLUTION; ORAL 1MG/5ML MCNEIL CONS HYDROCHLORIDE 3/1/1988 IMODIUM A-D LOPERAMIDE SUSPENSION; ORAL 1MG/7.5ML MCNEIL CONS HYDROCHLORIDE 5/23/1988 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG AMNEAL PHARMS NY 7/1/1988 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG CONTRACT PHARMACAL 8/11/1988 IBU-TAB 200 IBUPROFEN TABLET; ORAL 200MG ALRA 8/17/1988 ROGAINE (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% JOHNSON AND JOHNSON 8/17/1988 ROGAINE (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% JOHNSON AND JOHNSON 12/2/1988 PHARMASEAL SCRUB CHLORHEXIDINE GLUCONATE SPONGE; TOPICAL 4% PHARMASEAL CARE 3/31/1989 VISINE L.R. OXYMETAZOLINE SOLUTION/DROPS; 0.025% JOHNSON AND HYDROCHLORIDE OPHTHALMIC JOHNSON 3/31/1989 POVIDONE IODINE POVIDONE-IODINE SOLUTION; TOPICAL 1% ALLEGIANCE HLTHCARE 3/31/1989 BIOSCRUB CHLORHEXIDINE GLUCONATE SPONGE; TOPICAL 4% GRIFFEN 4/25/1989 HUMULIN 70/30 INSULIN RECOMBINANT INJECTABLE; INJECTION 30 UNITS/ML;70 UNITS/ML LILLY HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 4/25/1989 HUMULIN 70/30 PEN INSULIN RECOMBINANT INJECTABLE; INJECTION 30 UNITS/ML;70 UNITS/ML LILLY HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

Source: FDA.gov 33 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 9/19/1989 ADVIL COLD AND SINUS IBUPROFEN; TABLET; ORAL 200MG;30MG WYETH CONS PSEUDOEPHEDRINE HYDROCHLORIDE 10/24/1989 CHLORHEXIDINE CHLORHEXIDINE GLUCONATE SPONGE; TOPICAL 4% BECTON, DICKINSON GLUCONATE 10/27/1989 LOTRIMIN AF CLOTRIMAZOLE Cream; Topical 1% SCHERING-PLOUGH 10/27/1989 LOTRIMIN AF CLOTRIMAZOLE Lotion; Topical 1% SCHERING-PLOUGH 10/27/1989 LOTRIMIN AF CLOTRIMAZOLE Solution; Topical 1% SCHERING-PLOUGH 11/22/1989 IMODIUM A-D LOPERAMIDE TABLET; ORAL 2MG MCNEIL CONS HYDROCHLORIDE 5/2/1990 NIX PERMETHRIN LOTION; TOPICAL 1% INSIGHT PHARMS 6/25/1991 NOVOLIN R INSULIN RECOMBINANT INJECTABLE; INJECTION 100 UNITS/ML NOVO NORDISK INC HUMAN 6/25/1991 NOVOLIN 70/30 INSULIN RECOMBINANT INJECTABLE; INJECTION 30 UNITS/ML;70 UNITS/ML NOVO NORDISK INC HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 7/1/1991 NOVOLIN N INSULIN SUSP ISOPHANE INJECTABLE; INJECTION 100 UNITS/ML NOVO NORDISK INC RECOMBINANT HUMAN 10/31/1991 SUDAFED 12 HOUR PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE; 120MG MCNEIL CONS HYDROCHLORIDE ORAL 11/7/1991 NICODERM CQ NICOTINE FILM, EXTENDED RELEASE; 21MG/24HR SANOFI-AVENTIS US TRANSDERMAL 11/7/1991 NICODERM CQ NICOTINE FILM, EXTENDED RELEASE; 14MG/24HR SANOFI-AVENTIS US TRANSDERMAL 11/7/1991 NICODERM CQ NICOTINE FILM, EXTENDED RELEASE; 7MG/24HR SANOFI-AVENTIS US TRANSDERMAL 11/27/1991 HABITROL NICOTINE FILM, EXTENDED RELEASE; 7MG/24HR NOVARTIS TRANSDERMAL 11/27/1991 HABITROL NICOTINE FILM, EXTENDED RELEASE; 14MG/24HR NOVARTIS TRANSDERMAL 11/27/1991 HABITROL NICOTINE FILM, EXTENDED RELEASE; 21MG/24HR NOVARTIS TRANSDERMAL 1/21/1992 LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML PERRIGO HYDROCHLORIDE HYDROCHLORIDE 3/27/1992 ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG G AND W LABS 3/27/1992 ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 325MG G AND W LABS 4/30/1992 LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML ROXANE HYDROCHLORIDE HYDROCHLORIDE 6/8/1992 NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE GLAXOSMITHKLINE 6/8/1992 NICORETTE (MINT) NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE GLAXOSMITHKLINE 6/8/1992 NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE GLAXOSMITHKLINE 8/21/1992 TAVIST-1 CLEMASTINE FUMARATE TABLET; ORAL 1.34MG NOVARTIS 9/3/1992 BRONCHO SALINE SODIUM CHLORIDE AEROSOL, METERED; 0.9% BLAIREX INHALATION 12/7/1992 SHADE UVAGUARD AVOBENZONE; OCTINOXATE; LOTION; TOPICAL 3%;7.5%;3% SCHERING-PLOUGH OXYBENZONE 12/10/1992 LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG OHM LABS HYDROCHLORIDE HYDROCHLORIDE 12/15/1992 SUDAFED 24 HOUR PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE; 240MG MCNEIL CONS HYDROCHLORIDE ORAL 12/31/1992 SINE-AID IB IBUPROFEN; TABLET; ORAL 200MG;30MG MCNEIL CONS PSEUDOEPHEDRINE HYDROCHLORIDE 4/12/1993 CLARITIN LORATADINE TABLET; ORAL 10MG SCHERING-PLOUGH 4/12/1993 CLARITIN HIVES RELIEF LORATADINE TABLET; ORAL 10MG SCHERING-PLOUGH 4/26/1993 MONISTAT 7 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,100MG JOHNSON AND COMBINATION PACK TOPICAL, VAGINAL JOHNSON 4/26/1993 GYNE-LOTRIMIN CLOTRIMAZOLE CREAM, TABLET; TOPICAL, 1%,100MG SCHERING-PLOUGH COMBINATION PACK VAGINAL

Source: FDA.gov 34 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 7/16/1993 CLOTRIMAZOLE CLOTRIMAZOLE CREAM; VAGINAL 1% ACTAVIS MID ATLANTIC 7/30/1993 LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG CONTRACT PHARMACAL HYDROCHLORIDE HYDROCHLORIDE 10/31/1993 CLEMASTINE FUMARATE CLEMASTINE FUMARATE TABLET; ORAL 1.34MG SANDOZ 11/19/1993 MICONAZOLE NITRATE MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG ACTAVIS MID ATLANTIC 1/11/1994 ALEVE NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE BAYER 2/25/1994 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG CONTRACT PHARMACAL 3/30/1994 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG MCNEIL 6/8/1994 TYLENOL (CAPLET) ACETAMINOPHEN TABLET, EXTENDED RELEASE; 650MG MCNEIL CONS ORAL 6/8/1994 TYLENOL (GELTAB) ACETAMINOPHEN TABLET, EXTENDED RELEASE; 650MG MCNEIL CONS ORAL 6/8/1994 OPCON-A NAPHAZOLINE SOLUTION/DROPS; 0.02675%;0.315% BAUSCH AND LOMB HYDROCHLORIDE; OPHTHALMIC PHENIRAMINE MALEATE 6/8/1994 NAPHCON-A NAPHAZOLINE SOLUTION/DROPS; 0.025%;0.3% ALCON HYDROCHLORIDE; OPHTHALMIC PHENIRAMINE MALEATE 6/23/1994 MYCELEX-7 CLOTRIMAZOLE CREAM, TABLET; TOPICAL, 1%,100MG BAYER COMBINATION PACK VAGINAL PHARMACEUTICALS 11/14/1994 CLARITIN-D LORATADINE; TABLET, EXTENDED RELEASE; 5MG;120MG SCHERING-PLOUGH PSEUDOEPHEDRINE SULFATE ORAL 4/20/1995 ADVIL LIQUI-GELS IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID WYETH CONS AND POTASSIUM SALT 4/20/1995 ADVIL MIGRAINE LIQUI- IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID WYETH CONS GELS AND POTASSIUM SALT 4/28/1995 PEPCID AC FAMOTIDINE TABLET; ORAL 10MG MERCK SHARP DOHME 4/28/1995 PEPCID AC FAMOTIDINE TABLET; ORAL 20MG MERCK SHARP DOHME 6/16/1995 CHILDREN’S MOTRIN IBUPROFEN SUSPENSION; ORAL 100MG/5ML MCNEIL 6/19/1995 TAGAMET HB CIMETIDINE TABLET; ORAL 200MG GLAXOSMITHKLINE 11/17/1995 LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML HI TECH PHARMA HYDROCHLORIDE HYDROCHLORIDE 11/22/1995 CLEMASTINE FUMARATE CLEMASTINE FUMARATE TABLET; ORAL 1.34MG PERRIGO 12/4/1995 CLOTRIMAZOLE CLOTRIMAZOLE CREAM; VAGINAL 1% TARO 12/8/1995 ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG MCNEIL CONSUMER 12/8/1995 ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG MCNEIL CONSUMER 12/8/1995 ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG MCNEIL CONSUMER 12/8/1995 ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG MCNEIL CONSUMER 12/19/1995 ZANTAC 75 RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE BOEHRINGER INGELHEIM 12/21/1995 FEMSTAT 3 BUTOCONAZOLE NITRATE CREAM; VAGINAL 2% BAYER 1/31/1996 VISINE-A NAPHAZOLINE SOLUTION/DROPS; 0.025%;0.3% JOHNSON AND HYDROCHLORIDE; OPHTHALMIC JOHNSON PHENIRAMINE MALEATE 2/22/1996 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 2% G AND W LABS 3/29/1996 MICONAZOLE 7 MICONAZOLE NITRATE CREAM; VAGINAL 2% ACTAVIS MID ATLANTIC 4/5/1996 MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% ACTAVIS MID ATLANTIC 4/16/1996 MONISTAT-3 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,200MG JOHNSON AND COMBINATION PACK TOPICAL, VAGINAL JOHNSON 5/9/1996 AXID AR NIZATIDINE TABLET; ORAL 75MG WYETH CONS 6/10/1996 JUNIOR STRENGTH IBUPROFEN TABLET; ORAL 100MG MCNEIL CONS MOTRIN 6/10/1996 CHILDREN’S MOTRIN IBUPROFEN SUSPENSION/DROPS; ORAL 40MG/ML MCNEIL CONS 6/27/1996 CHILDREN’S ADVIL IBUPROFEN SUSPENSION; ORAL 100MG/5ML WYETH CONS 6/27/1996 CHILDREN’S ADVIL- IBUPROFEN SUSPENSION; ORAL 100MG/5ML WYETH CONS FLAVORED 7/29/1996 GYNE-LOTRIMIN 3 CLOTRIMAZOLE TABLET; VAGINAL 200MG SCHERING-PLOUGH

Source: FDA.gov 35 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 7/29/1996 GYNE-LOTRIMIN 3 CLOTRIMAZOLE CREAM, TABLET; TOPICAL, 1%,200MG SCHERING-PLOUGH COMBINATION PACK VAGINAL 8/23/1996 CLARITIN-D 24 HOUR LORATADINE; TABLET, EXTENDED RELEASE; 10MG;240MG SCHERING-PLOUGH PSEUDOEPHEDRINE SULFATE ORAL 8/26/1996 IVY BLOCK BENTOQUATAM LOTION; TOPICAL 5% STAND HOMEOPATH 9/18/1996 DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE TABLET; ORAL 25MG PERRIGO 10/10/1996 CLARITIN LORATADINE SYRUP; ORAL 1MG/ML SCHERING-PLOUGH 11/15/1996 CHILDREN’S MOTRIN IBUPROFEN TABLET, CHEWABLE; ORAL 50MG MCNEIL CONS 11/15/1996 JUNIOR STRENGTH IBUPROFEN TABLET, CHEWABLE; ORAL 100MG MCNEIL CONS MOTRIN 12/13/1996 JUNIOR STRENGTH ADVIL IBUPROFEN TABLET; ORAL 100MG WYETH CONS 12/23/1996 CLARITIN REDITABS LORATADINE TABLET, ORALLY 10MG SCHERING-PLOUGH DISINTEGRATING; ORAL 12/23/1996 CLARITIN HIVES RELIEF LORATADINE TABLET, ORALLY 10MG SCHERING-PLOUGH REDITAB DISINTEGRATING; ORAL 12/24/1996 MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% HI TECH PHARMA 12/24/1996 MINOXIDIL (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% HI TECH PHARMA 1/13/1997 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 2% TARO 1/13/1997 NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE CONTRACT PHARMACAL 1/13/1997 NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE SANDOZ 1/13/1997 NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE PERRIGO 2/11/1997 VAGISTAT-1 TIOCONAZOLE OINTMENT; VAGINAL 6.5% NOVARTIS 2/27/1997 NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE CONTRACT PHARMACAL 2/28/1997 MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% WOCKHARDT 3/20/1997 MICONAZOLE NITRATE MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG PERRIGO 4/30/1997 MICONAZOLE NITRATE MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG G AND W LABS 5/15/1997 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 2% PERRIGO 6/26/1997 IMODIUM MULTI- LOPERAMIDE TABLET, CHEWABLE; ORAL 2MG;125MG MCNEIL SYMPTOM RELIEF HYDROCHLORIDE; SIMETHICONE 7/11/1997 COLGATE TOTAL SODIUM FLUORIDE; PASTE; DENTAL 0.24%;0.3% COLGATE PALMOLIVE TRICLOSAN 7/17/1997 M-ZOLE 7 DUAL PACK MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,100MG ACTAVIS MID ATLANTIC TOPICAL, VAGINAL 7/24/1997 IMODIUM A-D EZ CHEWS LOPERAMIDE TABLET, CHEWABLE; ORAL 2MG MCNEIL HYDROCHLORIDE 8/28/1997 LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML WOCKHARDT HYDROCHLORIDE HYDROCHLORIDE 9/11/1997 DYNA-HEX CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL 0.75% XTTRIUM 10/10/1997 NIZORAL A-D KETOCONAZOLE SHAMPOO; TOPICAL 1% MCNEIL CONS 10/20/1997 NICOTINE NICOTINE FILM, EXTENDED RELEASE; 14MG/24HR AVEVA TRANSDERMAL 10/20/1997 NICOTINE NICOTINE FILM, EXTENDED RELEASE; 21MG/24HR AVEVA TRANSDERMAL 10/20/1997 NICOTINE NICOTINE FILM, EXTENDED RELEASE; 7MG/24HR AVEVA TRANSDERMAL 11/14/1997 ROGAINE EXTRA MINOXIDIL SOLUTION; TOPICAL 5% JOHNSON AND STRENGTH (FOR MEN) JOHNSON 1/14/1998 EXCEDRIN (MIGRAINE) ACETAMINOPHEN; ASPIRIN; TABLET; ORAL 250MG;250MG;65MG NOVARTIS CAFFEINE 1/30/1998 PEDIATRIC ADVIL IBUPROFEN SUSPENSION/DROPS; ORAL 100MG/2.5ML WYETH CONS 3/30/1998 MONISTAT 3 MICONAZOLE NITRATE CREAM; VAGINAL 4% JOHNSON AND JOHNSON 4/29/1998 MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% NOVEX 4/29/1998 MINOXIDIL (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% NOVEX 6/19/1998 CIMETIDINE CIMETIDINE TABLET; ORAL 200MG CONTRACT PHARMACAL

Source: FDA.gov 36 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 6/19/1998 CIMETIDINE CIMETIDINE TABLET; ORAL 200MG CONTRACT PHARMACAL 7/6/1998 IBUPROFEN IBUPROFEN CAPSULE; ORAL 200MG CONTRACT PHARMACAL 7/20/1998 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG CONTRACT PHARMACAL 7/28/1998 NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE DR REDDYS LABS INC 9/24/1998 PEPCID AC FAMOTIDINE TABLET, CHEWABLE; ORAL 20MG MERCK SHARP DOHME 10/29/1998 CIMETIDINE CIMETIDINE TABLET; ORAL 200MG PERRIGO 11/24/1998 GYNE-LOTRIMIN 3 CLOTRIMAZOLE CREAM; VAGINAL 2% SCHERING-PLOUGH 12/16/1998 IBUPROFEN IBUPROFEN SUSPENSION/DROPS; ORAL 40MG/ML PERRIGO 12/18/1998 CHILDREN’S ADVIL IBUPROFEN TABLET, CHEWABLE; ORAL 50MG WYETH CONS 12/18/1998 JUNIOR STRENGTH ADVIL IBUPROFEN TABLET, CHEWABLE; ORAL 100MG WYETH CONS 12/22/1998 CHILDREN’S IBUPROFEN IBUPROFEN SUSPENSION; ORAL 100MG/5ML PERRIGO 2/26/1999 PSEUDOEPHEDRINE PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE; 120MG PERRIGO HYDROCHLORIDE HYDROCHLORIDE ORAL 3/1/1999 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG LNK 3/1/1999 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG LNK 3/9/1999 LAMISIL TERBINAFINE HYDROCHLORIDE CREAM; TOPICAL 1% NOVARTIS 3/15/1999 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE WATSON LABS 3/19/1999 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE WATSON LABS 4/16/1999 M-ZOLE 3 COMBINATION MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,200MG ACTAVIS MID ATLANTIC PACK TOPICAL, VAGINAL 4/20/1999 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,200MG PERRIGO COMBINATION PACK TOPICAL, VAGINAL 4/22/1999 JUNIOR STRENGTH IBUPROFEN TABLET; ORAL 100MG PERRIGO IBUPROFEN 4/30/1999 IBUPROFEN IBUPROFEN SUSPENSION; ORAL 100MG/5ML ACTAVIS MID ATLANTIC 6/16/1999 CIMETIDINE CIMETIDINE TABLET; ORAL 200MG IVAX SUB TEVA PHARMS 6/21/1999 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE CONTRACT PHARMACAL HYDROCHLORIDE 7/2/1999 ZADITOR KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE NOVARTIS OPHTHALMIC 7/28/1999 PLAN B LEVONORGESTREL TABLET; ORAL 0.75MG DURAMED 7/29/1999 CIMETIDINE CIMETIDINE TABLET; ORAL 200MG WATSON LABS 7/30/1999 MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% PERRIGO 7/30/1999 MINOXIDIL (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% PERRIGO 8/5/1999 PEPCID AC (GELTAB) FAMOTIDINE TABLET; ORAL 10MG MERCK SHARP DOHME 11/29/1999 ALEVE-D SINUS & COLD NAPROXEN SODIUM; TABLET, EXTENDED RELEASE; 200MG;120MG BAYER PSEUDOEPHEDRINE ORAL HYDROCHLORIDE 1/6/2000 LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG PERRIGO HYDROCHLORIDE HYDROCHLORIDE 1/14/2000 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE WATSON LABS HYDROCHLORIDE 1/14/2000 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE IVAX SUB TEVA PHARMS HYDROCHLORIDE 1/14/2000 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE GENPHARM HYDROCHLORIDE 2/25/2000 ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED RELEASE; 650MG PERRIGO ORAL 3/7/2000 RID MOUSSE PIPERONYL BUTOXIDE; AEROSOL; TOPICAL 4%;EQ 0.33% BASE PFIZER PYRETHRINS 3/17/2000 LAMISIL AT TERBINAFINE HYDROCHLORIDE SOLUTION; TOPICAL 1% NOVARTIS 3/17/2000 LAMISIL AT TERBINAFINE HYDROCHLORIDE SPRAY; TOPICAL 1% NOVARTIS 3/28/2000 PERMETHRIN PERMETHRIN LOTION; TOPICAL 1% ACTAVIS MID ATLANTIC 3/28/2000 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE DR REDDYS LABS LTD HYDROCHLORIDE 4/12/2000 TRIVAGIZOLE 3 CLOTRIMAZOLE CREAM; VAGINAL 2% TARO

Source: FDA.gov 37 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 5/4/2000 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE TORPHARM HYDROCHLORIDE 7/14/2000 CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; SPONGE; TOPICAL 2%;70% (3ML) CAREFUSION ISOPROPYL ALCOHOL 7/14/2000 CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; SPONGE; TOPICAL 2%;70% (26ML) CAREFUSION ISOPROPYL ALCOHOL 7/14/2000 CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; SPONGE; TOPICAL 2%;70% (1.5ML) CAREFUSION FREPP ISOPROPYL ALCOHOL 7/14/2000 CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; SPONGE; TOPICAL 2%;70% (10.5ML) CAREFUSION ISOPROPYL ALCOHOL 7/14/2000 CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; SPONGE; TOPICAL 2%;70% (10.5ML) CAREFUSION ISOPROPYL ALCOHOL 7/14/2000 CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; SPONGE; TOPICAL 2%;70% (26ML) CAREFUSION ISOPROPYL ALCOHOL 7/14/2000 CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; SPONGE; TOPICAL 2%;70% (3ML) CAREFUSION ISOPROPYL ALCOHOL 7/25/2000 ABREVA DOCOSANOL CREAM; TOPICAL 10% GLAXOSMITHKLINE 8/1/2000 CHILDREN’S MOTRIN IBUPROFEN; SUSPENSION; ORAL 100MG/5ML;15MG/5ML MCNEIL CONS COLD PSEUDOEPHEDRINE HYDROCHLORIDE 10/16/2000 PEPCID COMPLETE CALCIUM CARBONATE; TABLET, CHEWABLE; ORAL 800MG;10MG;165MG MERCK SHARP DOHME FAMOTIDINE; MAGNESIUM HYDROXIDE 11/17/2000 MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% ACTAVIS MID ATLANTIC STRENGTH (FOR MEN) 11/17/2000 MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% AVACOR PRODS STRENGTH (FOR MEN) 11/30/2000 IMODIUM MULTI- LOPERAMIDE TABLET; ORAL 2MG;125MG MCNEIL CONS SYMPTOM RELIEF HYDROCHLORIDE; SIMETHICONE 2/2/2001 MONISTAT 3 MICONAZOLE NITRATE CREAM; TOPICAL, VAGINAL 2%,4% JOHNSON AND COMBINATION PACK JOHNSON (PREFILLED) 2/2/2001 MONISTAT 3 MICONAZOLE NITRATE CREAM; TOPICAL, VAGINAL 2%,4% JOHNSON AND COMBINATION PACK JOHNSON 3/1/2001 TAVIST ALLERGY/SINUS/ ACETAMINOPHEN; TABLET; ORAL 500MG;EQ 0.25MG NOVARTIS HEADACHE CLEMASTINE FUMARATE; BASE;30MG PSEUDOEPHEDRINE HYDROCHLORIDE 4/17/2001 IBUPROHM COLD AND IBUPROFEN; TABLET; ORAL 200MG;30MG OHM LABS SINUS PSEUDOEPHEDRINE HYDROCHLORIDE 5/31/2001 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG TEVA 6/7/2001 AVAGARD ALCOHOL; CHLORHEXIDINE SOLUTION; TOPICAL 61%;1% 3M GLUCONATE 6/13/2001 MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% PERRIGO STRENGTH (FOR MEN) 6/29/2001 MONISTAT 1 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,1.2GM JOHNSON AND COMBINATION PACK TOPICAL, VAGINAL JOHNSON 7/3/2001 CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY BAUSCH AND LOMB 7/26/2001 CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY ACTAVIS MID ATLANTIC 7/26/2001 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG IVAX SUB TEVA PHARMS 8/10/2001 ZYRTEC-D 12 HOUR CETIRIZINE HYDROCHLORIDE; TABLET, EXTENDED RELEASE; 5MG;120MG MCNEIL PSEUDOEPHEDRINE ORAL HYDROCHLORIDE 8/17/2001 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG DR REDDYS LABS LTD 10/1/2001 MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% NOVEX STRENGTH (FOR MEN) 11/20/2001 IBUPROFEN IBUPROFEN TABLET; ORAL 100MG DR REDDYS LABS INC 11/21/2001 TIOCONAZOLE TIOCONAZOLE OINTMENT; VAGINAL 6.5% PERRIGO 11/26/2001 ACETAMINOPHEN, ACETAMINOPHEN; ASPIRIN; TABLET; ORAL 250MG;250MG;65MG PERRIGO ASPIRIN AND CAFFEINE CAFFEINE

Source: FDA.gov 38 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 11/28/2001 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG WATSON LABS 12/7/2001 LOTRIMIN ULTRA BUTENAFINE HYDROCHLORIDE CREAM; TOPICAL 1% SCHERING-PLOUGH 12/12/2001 CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY PERRIGO 12/12/2001 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG DR REDDYS LA 12/20/2001 PERMETHRIN PERMETHRIN LOTION; TOPICAL 1% PERRIGO NEW YORK 12/21/2001 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG GENPHARM 3/14/2002 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG PERRIGO 3/15/2002 MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% PERRIGO NEW YORK STRENGTH (FOR MEN) 3/19/2002 ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED RELEASE; 650MG OHM LABS ORAL 4/8/2002 IBUPROFEN AND IBUPROFEN; TABLET; ORAL 200MG;30MG CONTRACT PHARMACAL PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE 4/18/2002 CHILDREN’S ADVIL COLD IBUPROFEN; SUSPENSION; ORAL 100MG/5ML;15MG/5ML WYETH CONS PSEUDOEPHEDRINE HYDROCHLORIDE 5/30/2002 ADVIL COLD AND SINUS IBUPROFEN; CAPSULE; ORAL EQ 200MG FREE ACID WYETH CONS PSEUDOEPHEDRINE AND POTASSIUM HYDROCHLORIDE SALT;30MG 7/12/2002 MUCINEX GUAIFENESIN TABLET, EXTENDED RELEASE; 600MG RECKITT BENCKISER ORAL 7/12/2002 MUCINEX GUAIFENESIN TABLET, EXTENDED RELEASE; 1.2GM RECKITT BENCKISER ORAL 8/30/2002 LOPERAMIDE LOPERAMIDE TABLET, CHEWABLE; ORAL 2MG;125MG PERRIGO HYDROCHLORIDE AND HYDROCHLORIDE; SIMETHICONE SIMETHICONE 8/30/2002 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE PERRIGO HYDROCHLORIDE 9/10/2002 THYROSAFE POTASSIUM IODIDE TABLET; ORAL 65MG RECIP 10/7/2002 CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; SWAB; TOPICAL 2%;70% (0.67ML) CAREFUSION SEPP ISOPROPYL ALCOHOL 10/7/2002 CHLORAPREP SINGLE CHLORHEXIDINE GLUCONATE; SWAB; TOPICAL 2%;70% (1.75ML) CAREFUSION SWABSTICK ISOPROPYL ALCOHOL 10/18/2002 MIDOL LIQUID GELS IBUPROFEN CAPSULE; ORAL 200MG BANNER PHARMACAPS 10/21/2002 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG SANDOZ 10/31/2002 COMMIT NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE GLAXOSMITHKLINE CONS 10/31/2002 COMMIT NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE GLAXOSMITHKLINE CONS 12/19/2002 ALAVERT LORATADINE TABLET, ORALLY 10MG WYETH CONS DISINTEGRATING; ORAL 12/19/2002 ADVIL ALLERGY SINUS CHLORPHENIRAMINE TABLET; ORAL 2MG;200MG;30MG WYETH CONS MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 1/21/2003 LORATADINE LORATADINE TABLET; ORAL 10MG SANDOZ 1/30/2003 LORATADINE AND LORATADINE; TABLET, EXTENDED RELEASE; 5MG;120MG IMPAX LABS PSEUDOEPHEDRINE PSEUDOEPHEDRINE SULFATE ORAL SULFATE 2/10/2003 LORATADINE LORATADINE TABLET, ORALLY 10MG WYETH CONS DISINTEGRATING; ORAL 2/21/2003 LORATADINE AND LORATADINE; TABLET, EXTENDED RELEASE; 10MG;240MG WATSON LABS FLORIDA PSEUDOEPHEDRINE PSEUDOEPHEDRINE SULFATE ORAL SULFATE 2/28/2003 MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% WOCKHARDT STRENGTH (FOR MEN) 6/10/2003 LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG LNK HYDROCHLORIDE HYDROCHLORIDE 6/20/2003 PRILOSEC OTC OMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE; EQ 20MG BASE ASTRAZENECA ORAL 8/18/2003 LORATADINE LORATADINE TABLET; ORAL 10MG RANBAXY

Source: FDA.gov 39 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 8/20/2003 LORATADINE LORATADINE TABLET; ORAL 10MG MYLAN 8/22/2003 FAMOTIDINE FAMOTIDINE TABLET, CHEWABLE; ORAL 10MG PERRIGO 9/29/2003 LORATADINE LORATADINE TABLET, ORALLY 10MG IMPAX LABS DISINTEGRATING; ORAL 11/3/2003 LORATADINE LORATADINE TABLET, ORALLY 10MG WATSON LABS FLORIDA DISINTEGRATING; ORAL 11/5/2003 IBUPROFEN AND IBUPROFEN; SUSPENSION; ORAL 100MG/5ML;15MG/5ML PERRIGO PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE 11/7/2003 LORATADINE LORATADINE SYRUP; ORAL 1MG/ML TEVA 11/26/2003 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG ADVENT PHARMS 1/7/2004 CHILDREN’S ELIXSURE IBUPROFEN SUSPENSION; ORAL 100MG/5ML ALTERNA TCHP LLC 1/16/2004 IBUPROFEN IBUPROFEN TABLET, CHEWABLE; ORAL 50MG PERRIGO 1/16/2004 IBUPROFEN IBUPROFEN TABLET, CHEWABLE; ORAL 100MG PERRIGO 1/28/2004 LORATADINE AND LORATADINE; TABLET, EXTENDED RELEASE; 5MG;120MG WATSON LABS FLORIDA PSEUDOEPHEDRINE PSEUDOEPHEDRINE SULFATE ORAL SULFATE 2/24/2004 CHILDREN’S ADVIL CHLORPHENIRAMINE SUSPENSION; ORAL 1MG/5ML; 100MG/5ML; WYETH CONS ALLERGY SINUS MALEATE; IBUPROFEN; 15MG/5ML PSEUDOEPHEDRINE HYDROCHLORIDE 3/4/2004 LORATADINE AND LORATADINE; TABLET, EXTENDED RELEASE; 10MG;240MG IMPAX LABS PSEUDOEPHEDRINE PSEUDOEPHEDRINE SULFATE ORAL SULFATE 3/16/2004 CHILDREN’S ZYRTEC CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 5MG PFIZER ALLERGY 3/16/2004 CHILDREN’S ZYRTEC CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 10MG PFIZER ALLERGY 3/16/2004 CHILDREN’S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 5MG PFIZER RELIEF 3/16/2004 CHILDREN’S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 10MG PFIZER RELIEF 3/17/2004 NAPROXEN SODIUM NAPROXEN SODIUM; TABLET, EXTENDED RELEASE; EQ 200MG BASE;120MG PERRIGO AND PSEUDOEPHEDRINE PSEUDOEPHEDRINE ORAL HYDROCHLORIDE HYDROCHLORIDE 3/26/2004 MICONAZOLE 7 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,100MG G AND W LABS COMBINATION PACK TOPICAL, VAGINAL 3/30/2004 MICONAZOLE 3 MICONAZOLE NITRATE CREAM; TOPICAL, VAGINAL 2%,4% PERRIGO COMBINATION PACK 4/29/2004 MUCINEX DM DEXTROMETHORPHAN TABLET, EXTENDED RELEASE; 60MG;1.2GM RECKITT BENCKISER HYDROBROMIDE; ORAL GUAIFENESIN 4/29/2004 MUCINEX DM DEXTROMETHORPHAN TABLET, EXTENDED RELEASE; 30MG;600MG RECKITT BENCKISER HYDROBROMIDE; ORAL GUAIFENESIN 6/17/2004 IBUPROFEN IBUPROFEN TABLET; ORAL 100MG LNK 6/22/2004 MUCINEX D GUAIFENESIN; TABLET, EXTENDED RELEASE; 600MG;60MG RECKITT BENCKISER PSEUDOEPHEDRINE ORAL HYDROCHLORIDE 6/22/2004 MUCINEX D GUAIFENESIN; TABLET, EXTENDED RELEASE; 1.2GM;120MG RECKITT BENCKISER PSEUDOEPHEDRINE ORAL HYDROCHLORIDE 6/25/2004 LORATADINE LORATADINE TABLET; ORAL 10MG PERRIGO 7/29/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE WATSON LABS 7/29/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE WATSON LABS 8/20/2004 LORATADINE LORATADINE SYRUP; ORAL 1MG/ML PERRIGO 8/20/2004 LORATADINE LORATADINE SYRUP; ORAL 1MG/ML WOCKHARDT 8/20/2004 LORATADINE LORATADINE SYRUP; ORAL 1MG/ML RANBAXY 8/20/2004 LORATADINE LORATADINE SYRUP; ORAL 1MG/ML TARO 8/24/2004 THEROXIDIL MINOXIDIL SOLUTION; TOPICAL 5% HARMONY LABS

Source: FDA.gov 40 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 8/27/2004 DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE TABLET; ORAL 25MG LNK 8/31/2004 ZANTAC 150 RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 150MG BASE BOEHRINGER INGELHEIM 8/31/2004 ZANTAC 150 RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 150MG BASE BOEHRINGER INGELHEIM 9/16/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE PERRIGO 9/16/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE PERRIGO 9/16/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE PERRIGO 9/16/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE PERRIGO 9/16/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE PERRIGO 9/16/2004 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE PERRIGO 9/22/2004 LORATADINE AND LORATADINE; TABLET, EXTENDED RELEASE; 10MG;240MG RANBAXY PSEUDOEPHEDRINE PSEUDOEPHEDRINE SULFATE ORAL SULFATE 10/5/2004 LORATADINE LORATADINE SYRUP; ORAL 1MG/ML APOTEX INC 10/5/2004 LORATADINE LORATADINE SYRUP; ORAL 5MG/5ML APOTEX INC 1/12/2005 THYROSHIELD POTASSIUM IODIDE SOLUTION; ORAL 65MG/ML FLEMING 3/2/2005 MICONAZOLE 3 MICONAZOLE NITRATE CREAM; VAGINAL 4% TARO 3/7/2005 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG WOCKHARDT 3/18/2005 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG PERRIGO 4/25/2005 CHLORHEXIDINE CHLORHEXIDINE GLUCONATE CLOTH; TOPICAL 2% SAGE PRODS GLUCONATE 6/3/2005 CHLORASCRUB SWAB CHLORHEXIDINE GLUCONATE; SWAB; TOPICAL 3.15%;70% (1ML) SOLUMED ISOPROPYL ALCOHOL 6/3/2005 CHLORASCRUB CHLORHEXIDINE GLUCONATE; SWAB; TOPICAL 3.15%;70% (1.6ML) SOLUMED SWABSTICK ISOPROPYL ALCOHOL 6/3/2005 CHLORASCRUB MAXI CHLORHEXIDINE GLUCONATE; SWAB; TOPICAL 3.15%;70% (5.1ML) SOLUMED SWABSTICK ISOPROPYL ALCOHOL 6/21/2005 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG PERRIGO R&D 8/4/2005 LOPERAMIDE LOPERAMIDE CAPSULE; ORAL 1MG BANNER PHARMACAPS HYDROCHLORIDE HYDROCHLORIDE 8/4/2005 LOPERAMIDE LOPERAMIDE CAPSULE; ORAL 2MG BANNER PHARMACAPS HYDROCHLORIDE HYDROCHLORIDE 9/28/2005 PSEUDOEPHEDRINE PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE; 120MG RANBAXY HYDROCHLORIDE HYDROCHLORIDE ORAL 10/4/2005 LORATADINE LORATADINE SUSPENSION; ORAL 1MG/ML TARO 12/21/2005 ADVIL PM DIPHENHYDRAMINE CAPSULE; ORAL 25MG;EQ 200MG FREE WYETH CONS HYDROCHLORIDE; IBUPROFEN ACID AND POTASSIUM SALT 12/21/2005 ADVIL PM DIPHENHYDRAMINE CITRATE; TABLET; ORAL 38MG;200MG WYETH CONS IBUPROFEN 1/20/2006 MEN’S ROGAINE MINOXIDIL AEROSOL, FOAM; TOPICAL 5% JOHNSON AND JOHNSON 1/31/2006 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE PERRIGO R&D 1/31/2006 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE PERRIGO R&D 2/14/2006 LORATADINE LORATADINE TABLET; ORAL 10MG APOTEX INC 2/17/2006 NAPROXEN SODIUM NAPROXEN SODIUM CAPSULE; ORAL EQ 200MG BASE BANNER PHARMACAPS 2/24/2006 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE WOCKHARDT HYDROCHLORIDE 5/9/2006 KETOTIFEN FUMARATE KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE APOTEX INC OPHTHALMIC 6/29/2006 LORATADINE LORATADINE SYRUP; ORAL 1MG/ML SILARX 7/21/2006 ANTHELIOS SX AVOBENZONE; ECAMSULE; CREAM; TOPICAL 2%;2%;10% L’OREAL USA OCTOCRYLENE 7/24/2006 LAMISIL AT TERBINAFINE GEL; TOPICAL 1% NOVARTIS 8/14/2006 IBUPROFEN AND IBUPROFEN; TABLET; ORAL 200MG;30MG DR REDDYS LABS LTD PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE 8/23/2006 CHILDREN’S CLARITIN LORATADINE TABLET, CHEWABLE; ORAL 5MG SCHERING-PLOUGH

Source: FDA.gov 41 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 9/6/2006 LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG;125MG RANBAXY HYDROCHLORIDE AND HYDROCHLORIDE; SIMETHICONE SIMETHICONE 9/25/2006 FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG PERRIGO 9/25/2006 FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG DR REDDYS LABS LTD 9/27/2006 NAPROXEN SODIUM NAPROXEN SODIUM; TABLET, EXTENDED RELEASE; EQ 220MG BASE;120MG DR REDDYS LABS INC AND PSEUDOEPHEDRINE PSEUDOEPHEDRINE ORAL HYDROCHLORIDE HYDROCHLORIDE 9/29/2006 DURAPREP IODINE POVACRYLEX; SPONGE; TOPICAL EQ 0.7% IODINE;74% (6ML) 3M ISOPROPYL ALCOHOL 9/29/2006 DURAPREP IODINE POVACRYLEX; SPONGE; TOPICAL EQ 0.7% IODINE;74% 3M ISOPROPYL ALCOHOL (26ML) 10/2/2006 CAPITAL SOLEIL 15 AVOBENZONE; ECAMSULE; CREAM; TOPICAL 2%;3%;10% L’OREAL USA OCTOCRYLENE 10/5/2006 ANTHELIOS 20 AVOBENZONE; ECAMSULE; CREAM; TOPICAL 2%;2%;10%;2% L’OREAL USA OCTOCRYLENE; TITANIUM DIOXIDE 10/6/2006 MIRALAX POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/SCOOPFUL SCHERING-PLOUGH 10/30/2006 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE PERRIGO R&D 10/30/2006 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE PERRIGO R&D 12/1/2006 ALAWAY KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE BAUSCH AND LOMB OPHTHALMIC 12/12/2006 CLARITIN REDITABS LORATADINE TABLET, ORALLY 5MG SCHERING-PLOUGH DISINTEGRATING; ORAL 2/7/2007 ALLI ORLISTAT CAPSULE; ORAL 60MG GLAXOSMITHKLINE CONS 4/11/2007 LORATADINE REDIDOSE LORATADINE TABLET, ORALLY 10MG RANBAXY DISINTEGRATING; ORAL 5/24/2007 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE PERRIGO R&D 5/24/2007 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE PERRIGO R&D 6/19/2007 THRIVE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE NOVARTIS 6/19/2007 THRIVE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE NOVARTIS 7/2/2007 TERBINAFINE TERBINAFINE HYDROCHLORIDE CREAM; TOPICAL 1% TARO HYDROCHLORIDE 7/26/2007 KETOTIFEN FUMARATE KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE AKORN OPHTHALMIC 8/31/2007 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 150MG BASE DR REDDYS LABS LTD HYDROCHLORIDE 9/7/2007 CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY QPHARMA 11/9/2007 THEROXIDIL MINOXIDIL SOLUTION; TOPICAL 2% HARMONY LABS 11/16/2007 CHILDREN’S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML MCNEIL CONSUMER RELIEF 11/16/2007 CHILDREN’S ZYRTEC CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML MCNEIL CONSUMER ALLERGY 11/26/2007 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 150MG BASE WOCKHARDT HYDROCHLORIDE 12/4/2007 OMEPRAZOLE OMEPRAZOLE TABLET, DELAYED RELEASE; 20MG DEXCEL PHARMA ORAL 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG CONTRACT PHARMA HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG CONTRACT PHARMA HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG MYLAN HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG MYLAN HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG MYLAN HYDROCHLORIDE HIVES

Source: FDA.gov 42 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG MYLAN HYDROCHLORIDE HIVES 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG RANBAXY HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG RANBAXY HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG RANBAXY HYDROCHLORIDE HIVES 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG RANBAXY HYDROCHLORIDE HIVES 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG CARACO HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG CARACO HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG CARACO HYDROCHLORIDE HIVES 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG CARACO HYDROCHLORIDE HIVES 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG SANDOZ HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG SANDOZ HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG APOTEX INC HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG APOTEX INC HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG PERRIGO R&D HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG PERRIGO R&D HYDROCHLORIDE ALLERGY 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG PERRIGO R&D HYDROCHLORIDE HIVES 12/27/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG PERRIGO R&D HYDROCHLORIDE HIVES 12/28/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG WOCKHARDT HYDROCHLORIDE ALLERGY 12/28/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG WOCKHARDT HYDROCHLORIDE ALLERGY 12/28/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG ACTAVIS ELIZABETH HYDROCHLORIDE ALLERGY 12/28/2007 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG ACTAVIS ELIZABETH HYDROCHLORIDE ALLERGY 1/11/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 5MG CARACO HYDROCHLORIDE HIVES RELIEF 1/11/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 10MG CARACO HYDROCHLORIDE HIVES RELIEF 1/11/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 10MG CARACO HYDROCHLORIDE ALLERGY

Source: FDA.gov 43 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 1/11/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 5MG CARACO HYDROCHLORIDE ALLERGY 1/15/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG DR REDDYS LABS LTD HYDROCHLORIDE HIVES 1/15/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG DR REDDYS LABS LTD HYDROCHLORIDE HIVES 1/15/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG DR REDDYS LABS LTD HYDROCHLORIDE ALLERGY 1/15/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG DR REDDYS LABS LTD HYDROCHLORIDE ALLERGY 2/6/2008 CALCIUM CARBONATE, CALCIUM CARBONATE; TABLET, CHEWABLE; ORAL 800MG;10MG;165MG PERRIGO R&D FAMOTIDINE AND FAMOTIDINE; MAGNESIUM MAGNESIUM HYDROXIDE HYDROXIDE 2/14/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 5MG SANDOZ HYDROCHLORIDE ALLERGY 2/14/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE; ORAL 10MG SANDOZ HYDROCHLORIDE ALLERGY 2/20/2008 SALONPAS MENTHOL; METHYL SALICYLATE PATCH; TOPICAL 3%;10% HISAMITSU 2/25/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE; TABLET, EXTENDED RELEASE; 5MG;120MG IVAX SUB TEVA PHARMS HYDROCHLORIDE AND PSEUDOEPHEDRINE ORAL PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE 3/5/2008 CETIRIZINE CETIRIZINE HYDROCHLORIDE; TABLET, EXTENDED RELEASE; 5MG;120MG SANDOZ HYDROCHLORIDE AND PSEUDOEPHEDRINE ORAL PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE 3/31/2008 ANTHELIOS 40 AVOBENZONE; ECAMSULE; CREAM; TOPICAL 2%;3%;10%;5% L’OREAL USA OCTOCRYLENE; TITANIUM DIOXIDE 3/31/2008 ANTHELIOS 40 AVOBENZONE; ECAMSULE; CREAM; TOPICAL 2%;3%;10%;5% L’OREAL USA OCTOCRYLENE; TITANIUM DIOXIDE 4/9/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML PERRIGO R&D HYDROCHLORIDE HIVES RELIEF 4/9/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML PERRIGO R&D HYDROCHLORIDE ALLERGY 4/22/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML TARO HYDROCHLORIDE HIVES RELIEF 4/22/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML TARO HYDROCHLORIDE ALLERGY 4/23/2008 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE PERRIGO R&D 4/23/2008 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE PERRIGO R&D 4/24/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML RANBAXY HYDROCHLORIDE HIVES RELIEF 4/24/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML RANBAXY HYDROCHLORIDE ALLERGY 6/16/2008 CLARITIN LORATADINE CAPSULE; ORAL 10MG SCHERING-PLOUGH 7/31/2008 RANITIDINE RANITIDINE HYDROCHLORIDE TABLET; ORAL EQ 75MG BASE WOCKHARDT HYDROCHLORIDE 9/2/2008 KETOTIFEN FUMARATE KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE ALCON OPHTHALMIC 10/10/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML CYPRESS PHARM HYDROCHLORIDE ALLERGY

Source: FDA.gov 44 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 10/10/2008 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML CYPRESS PHARM HYDROCHLORIDE HIVES RELIEF 11/7/2008 LORATADINE LORATADINE TABLET; ORAL 10MG MYLAN 12/16/2008 NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE AMNEAL PHARMS NY 12/22/2008 IBUPROFEN AND DIPHENHYDRAMINE CITRATE; TABLET; ORAL 38MG;200MG PERRIGO R&D DIPHENHYDRAMINE IBUPROFEN CITRATE 12/29/2008 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE WATSON LABS 12/29/2008 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE WATSON LABS 2/18/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE IVAX SUB TEVA PHARMS 2/18/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE IVAX SUB TEVA PHARMS 2/19/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG ORCHID HLTHCARE HYDROCHLORIDE ALLERGY 2/19/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG ORCHID HLTHCARE HYDROCHLORIDE ALLERGY 2/19/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG ORCHID HLTHCARE HYDROCHLORIDE HIVES 2/19/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG ORCHID HLTHCARE HYDROCHLORIDE HIVES 3/24/2009 IBUPROFEN IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID BANNER PHARMACAPS AND POTASSIUM SALT 3/30/2009 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML DR REDDYS LABS LTD HYDROCHLORIDE HIVES RELIEF 3/30/2009 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML DR REDDYS LABS LTD HYDROCHLORIDE ALLERGY 5/13/2009 CHLORPHENIRAMINE CHLORPHENIRAMINE MALEATE TABLET, EXTENDED RELEASE; 12MG AVANTHI INC MALEATE ORAL 5/18/2009 PREVACID 24 HR LANSOPRAZOLE CAPSULE, DELAYED REL 15MG NOVARTIS PELLETS; ORAL 5/18/2009 NICORETTE NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE GLAXOSMITHKLINE CONS 5/18/2009 NICORETTE NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE GLAXOSMITHKLINE CONS 6/5/2009 OMEPRAZOLE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE; EQ 20MG BASE DR REDDYS LABS LTD MAGNESIUM ORAL 6/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG UNICHEM HYDROCHLORIDE HIVES 6/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG UNICHEM HYDROCHLORIDE HIVES 6/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG UNICHEM HYDROCHLORIDE ALLERGY 6/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG UNICHEM HYDROCHLORIDE ALLERGY 6/26/2009 IBUPROFEN IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID MARKSANS PHARMA AND POTASSIUM SALT 7/8/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE WATSON LABS 7/8/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE WATSON LABS 7/8/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE WATSON LABS 7/8/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE WATSON LABS 7/8/2009 IBUPROFEN AND DIPHENHYDRAMINE CITRATE; TABLET; ORAL 38MG;200MG DR REDDYS LABS LTD DIPHENHYDRAMINE IBUPROFEN CITRATE 7/10/2009 PLAN B ONE-STEP LEVONORGESTREL TABLET; ORAL 1.5MG DURAMED 7/10/2009 IBUPROFEN IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID DR REDDYS LABS LTD AND POTASSIUM SALT 7/10/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE PERRIGO R&D

Source: FDA.gov 45 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 7/10/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE PERRIGO R&D 7/10/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE PERRIGO R&D 7/10/2009 NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE PERRIGO R&D 7/22/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG TARO HYDROCHLORIDE ALLERGY 7/22/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG TARO HYDROCHLORIDE HIVES RELIEF 7/22/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG TARO HYDROCHLORIDE ALLERGY 7/22/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG TARO HYDROCHLORIDE HIVES RELIEF 7/23/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE CAPSULE; ORAL 5MG BANNER PHARMACAPS HYDROCHLORIDE ALLERGY 7/23/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE CAPSULE; ORAL 10MG BANNER PHARMACAPS HYDROCHLORIDE HIVES RELIEF 7/23/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE CAPSULE; ORAL 5MG BANNER PHARMACAPS HYDROCHLORIDE HIVES RELIEF 7/23/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE CAPSULE; ORAL 10MG BANNER PHARMACAPS HYDROCHLORIDE ALLERGY 8/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG UNIQUE PHARM LABS HYDROCHLORIDE ALLERGY 8/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG UNIQUE PHARM LABS HYDROCHLORIDE HIVES 8/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG UNIQUE PHARM LABS HYDROCHLORIDE HIVES 8/26/2009 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG UNIQUE PHARM LABS HYDROCHLORIDE ALLERGY 8/28/2009 LEVONORGESTREL LEVONORGESTREL TABLET; ORAL 0.75MG WATSON LABS 8/31/2009 IBUPROFEN IBUPROFEN SUSPENSION/DROPS; ORAL 40MG/ML TRIS PHARMA INC 10/6/2009 POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/PACKET MYLAN 3350 10/6/2009 POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/SCOOPFUL MYLAN 3350 10/6/2009 GLYCOLAX POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/PACKET KREMERS URBAN PHARMS 10/6/2009 GLYCOLAX POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/SCOOPFUL KREMERS URBAN PHARMS 10/6/2009 POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/PACKET PERRIGO R&D 3350 10/6/2009 POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/SCOOPFUL PERRIGO R&D 3350 10/6/2009 POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/SCOOPFUL NOVEL LABS INC 3350 10/7/2009 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML AMNEAL PHARMS HYDROCHLORIDE HIVES RELIEF 10/7/2009 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML AMNEAL PHARMS HYDROCHLORIDE ALLERGY 10/7/2009 POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/SCOOPFUL NEXGEN PHARMA 3350 10/15/2009 POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL 17GM/SCOOPFUL PADDOCK 3350 11/17/2009 FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG RANBAXY 11/17/2009 FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG RANBAXY

Source: FDA.gov 46 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 11/18/2009 ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED RELEASE; 650MG RANBAXY ORAL 11/25/2009 NEXCEDE KETOPROFEN FILM; ORAL 12.5MG NOVARTIS 12/1/2009 ZEGERID OTC OMEPRAZOLE; SODIUM CAPSULE; ORAL 20MG;1.1GM SCHERING-PLOUGH BICARBONATE 1/15/2010 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 4% PERRIGO R&D 1/21/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG AMNEAL PHARMS NY HYDROCHLORIDE ALLERGY 1/21/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG AMNEAL PHARMS NY HYDROCHLORIDE HIVES RELIEF 1/21/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG AMNEAL PHARMS NY HYDROCHLORIDE HIVES RELIEF 1/21/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG AMNEAL PHARMS NY HYDROCHLORIDE ALLERGY 2/2/2010 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML AUROBINDO PHARMA HYDROCHLORIDE HIVES RELIEF 2/2/2010 CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML AUROBINDO PHARMA HYDROCHLORIDE ALLERGY 4/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG TORRENT PHARMS LLC HYDROCHLORIDE ALLERGY 4/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG TORRENT PHARMS LLC HYDROCHLORIDE HIVES RELIEF 4/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG TORRENT PHARMS LLC HYDROCHLORIDE HIVES RELIEF 4/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG TORRENT PHARMS LLC HYDROCHLORIDE ALLERGY 5/27/2010 ADVIL CONGESTION IBUPROFEN; PHENYLEPHRINE TABLET; ORAL 200MG;10MG WYETH CONS RELIEF HYDROCHLORIDE 6/2/2010 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,1.2GM PERRIGO R&D TOPICAL, VAGINAL 6/2/2010 MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; TOPICAL, VAGINAL 2% PERRIGO R&D 6/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG CADISTA PHARMS HYDROCHLORIDE ALLERGY 6/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG CADISTA PHARMS HYDROCHLORIDE ALLERGY 6/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 5MG CADISTA PHARMS HYDROCHLORIDE HIVES 6/15/2010 CETIRIZINE CETIRIZINE HYDROCHLORIDE TABLET; ORAL 10MG CADISTA PHARMS HYDROCHLORIDE HIVES 8/4/2010 FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG WOCKHARDT 9/3/2010 ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET, ORALLY 10MG MCNEIL CONSUMER DISINTEGRATING; ORAL 9/27/2010 NAPHAZOLINE NAPHAZOLINE SOLUTION/DROPS; 0.02675%;0.315% ALTAIRE PHARMS INC HYDROCHLORIDE AND HYDROCHLORIDE; OPHTHALMIC PHENIRAMINE MALEATE PHENIRAMINE MALEATE 11/22/2010 IBUPROFEN AND DIPHENHYDRAMINE CAPSULE; ORAL 25MG;EQ 200MG FREE BANNER PHARMACAPS DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN ACID AND POTASSIUM SALT 12/10/2010 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG GRANULES INDIA 12/30/2010 LEVONORGESTREL LEVONORGESTREL TABLET; ORAL 0.75MG PERRIGO R&D 12/30/2010 LEVONORGESTREL LEVONORGESTREL TABLET; ORAL 0.75MG PERRIGO R&D

Source: FDA.gov 47 FDA OTC Approvals On The Market: By Action Date

Action Date Drug Name Active Ingredient Form Dosage Sponsor Applicant 1/24/2011 ALLEGRA ALLERGY; FEXOFENADINE SUSPENSION; ORAL 30MG/5ML SANOFI-AVENTIS US ALLEGRA HIVES HYDROCHLORIDE 2/1/2011 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG MARKSANS PHARMA 2/8/2011 IBUPROFEN IBUPROFEN TABLET; ORAL 200MG MARKSANS PHARMA — CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML APOTEX HYDROCHLORIDE HIVES RELIEF — CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML APOTEX HYDROCHLORIDE ALLERGY — CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML ACTAVIS MID ATLANTIC HYDROCHLORIDE HIVES RELIEF — CHILDREN’S CETIRIZINE CETIRIZINE HYDROCHLORIDE SYRUP; ORAL 5MG/5ML ACTAVIS MID ATLANTIC HYDROCHLORIDE ALLERGY Source: FDA.gov Notes: This listing contains over-the-counter human drugs currently approved by FDA for sale in the United States. This listing does not include over-the-counter products approved for marketing by FDA through a process other than submission of a New Drug Application or Biologic License Application. Also excluded are dietary supplements, which do not require FDA approval to be sold in the United States.

FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date 3M AVAGARD ALCOHOL; SOLUTION; TOPICAL 61%;1% 6/7/2001 CHLORHEXIDINE GLUCONATE 3M DURAPREP IODINE POVACRYLEX; SPONGE; TOPICAL EQ 0.7% IODINE;74% (6ML) 9/29/2006 ISOPROPYL ALCOHOL 3M DURAPREP IODINE POVACRYLEX; SPONGE; TOPICAL EQ 0.7% IODINE;74% 9/29/2006 ISOPROPYL ALCOHOL (26ML) ACTAVIS ELIZABETH CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/28/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY ACTAVIS ELIZABETH CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/28/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY ACTAVIS MID ATLANTIC ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG 4/22/1980 ACTAVIS MID ATLANTIC ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 325MG 4/22/1980 ACTAVIS MID ATLANTIC ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG 4/22/1980 ACTAVIS MID ATLANTIC CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML — HYDROCHLORIDE HYDROCHLORIDE ALLERGY ACTAVIS MID ATLANTIC CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML — HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF ACTAVIS MID ATLANTIC CLOTRIMAZOLE CLOTRIMAZOLE CREAM; VAGINAL 1% 7/16/1993 ACTAVIS MID ATLANTIC CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY 7/26/2001 ACTAVIS MID ATLANTIC IBUPROFEN IBUPROFEN SUSPENSION; ORAL 100MG/5ML 4/30/1999 ACTAVIS MID ATLANTIC INFANTS’ FEVERALL ACETAMINOPHEN SUPPOSITORY; RECTAL 80MG 4/22/1980 ACTAVIS MID ATLANTIC MICONAZOLE 7 MICONAZOLE NITRATE CREAM; VAGINAL 2% 3/29/1996 ACTAVIS MID ATLANTIC MICONAZOLE NITRATE MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG 11/19/1993 ACTAVIS MID ATLANTIC MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% 4/5/1996 ACTAVIS MID ATLANTIC MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% 11/17/2000 STRENGTH (FOR MEN) ACTAVIS MID ATLANTIC M-ZOLE 3 COMBINATION MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,200MG 4/16/1999 PACK TOPICAL, VAGINAL

Source: FDA.gov 48 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date ACTAVIS MID ATLANTIC M-ZOLE 7 DUAL PACK MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,100MG 7/17/1997 TOPICAL, VAGINAL ACTAVIS MID ATLANTIC PERMETHRIN PERMETHRIN LOTION; TOPICAL 1% 3/28/2000 ADVENT PHARMS IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 11/26/2003 AKORN KETOTIFEN FUMARATE KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE 7/26/2007 OPHTHALMIC ALCON KETOTIFEN FUMARATE KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE 9/2/2008 OPHTHALMIC ALCON NAPHCON-A NAPHAZOLINE SOLUTION/DROPS; 0.025%;0.3% 6/8/1994 HYDROCHLORIDE; OPHTHALMIC PHENIRAMINE MALEATE ALLEGIANCE HLTHCARE POVIDONE IODINE POVIDONE-IODINE SOLUTION; TOPICAL 1% 3/31/1989 ALRA IBU-TAB 200 IBUPROFEN TABLET; ORAL 200MG 8/11/1988 ALTAIRE PHARMS INC NAPHAZOLINE NAPHAZOLINE SOLUTION/DROPS; 0.02675%;0.315% 9/27/2010 HYDROCHLORIDE AND HYDROCHLORIDE; OPHTHALMIC PHENIRAMINE MALEATE PHENIRAMINE MALEATE ALTERNA TCHP LLC CHILDREN’S ELIXSURE IBUPROFEN SUSPENSION; ORAL 100MG/5ML 1/7/2004 AMNEAL PHARMS CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 10/7/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY AMNEAL PHARMS CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 10/7/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF AMNEAL PHARMS NY CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 1/21/2010 HYDROCHLORIDE HYDROCHLORIDE ALLERGY AMNEAL PHARMS NY CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 1/21/2010 HYDROCHLORIDE HYDROCHLORIDE ALLERGY AMNEAL PHARMS NY CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 1/21/2010 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF AMNEAL PHARMS NY CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 1/21/2010 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF AMNEAL PHARMS NY IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 2/17/1987 AMNEAL PHARMS NY IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 5/23/1988 AMNEAL PHARMS NY NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE 12/16/2008 ANBEX IOSAT POTASSIUM IODIDE TABLET; ORAL 130MG 10/14/1982 APOTEX CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML — HYDROCHLORIDE HYDROCHLORIDE ALLERGY APOTEX CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML — HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF APOTEX INC CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY APOTEX INC CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY APOTEX INC KETOTIFEN FUMARATE KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE 5/9/2006 OPHTHALMIC APOTEX INC LORATADINE LORATADINE SYRUP; ORAL 1MG/ML 10/5/2004 APOTEX INC LORATADINE LORATADINE SYRUP; ORAL 5MG/5ML 10/5/2004 APOTEX INC LORATADINE LORATADINE TABLET; ORAL 10MG 2/14/2006 ARMSTRONG PHARMS EPINEPHRINE EPINEPHRINE AEROSOL, METERED; 0.2MG/INH 5/23/1984 INHALATION ASTRAZENECA PRILOSEC OTC OMEPRAZOLE TABLET, DELAYED RELEASE; EQ 20MG BASE 6/20/2003 MAGNESIUM ORAL

Source: FDA.gov 49 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date AUROBINDO PHARMA CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 2/2/2010 HYDROCHLORIDE HYDROCHLORIDE ALLERGY AUROBINDO PHARMA CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 2/2/2010 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF AVACOR PRODS MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% 11/17/2000 STRENGTH (FOR MEN) AVANTHI INC CHLORPHENIRAMINE CHLORPHENIRAMINE TABLET, EXTENDED 12MG 5/13/2009 MALEATE MALEATE RELEASE; ORAL AVEVA NICOTINE NICOTINE FILM, EXTENDED RELEASE; 14MG/24HR 10/20/1997 TRANSDERMAL AVEVA NICOTINE NICOTINE FILM, EXTENDED RELEASE; 21MG/24HR 10/20/1997 TRANSDERMAL AVEVA NICOTINE NICOTINE FILM, EXTENDED RELEASE; 7MG/24HR 10/20/1997 TRANSDERMAL AZTIQ PHARMA TODAY NONOXYNOL-9 SPONGE; VAGINAL 1GM 4/1/1983 BANNER PHARMACAPS CETIRIZINE CETIRIZINE CAPSULE; ORAL 5MG 7/23/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY BANNER PHARMACAPS CETIRIZINE CETIRIZINE CAPSULE; ORAL 10MG 7/23/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY BANNER PHARMACAPS CETIRIZINE CETIRIZINE CAPSULE; ORAL 10MG 7/23/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF BANNER PHARMACAPS CETIRIZINE CETIRIZINE CAPSULE; ORAL 5MG 7/23/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF BANNER PHARMACAPS IBUPROFEN IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID 3/24/2009 AND POTASSIUM SALT BANNER PHARMACAPS IBUPROFEN AND DIPHENHYDRAMINE CAPSULE; ORAL 25MG;EQ 200MG FREE 11/22/2010 DIPHENHYDRAMINE HYDROCHLORIDE; ACID AND POTASSIUM IBUPROFEN SALT BANNER PHARMACAPS LOPERAMIDE LOPERAMIDE CAPSULE; ORAL 1MG 8/4/2005 HYDROCHLORIDE HYDROCHLORIDE BANNER PHARMACAPS LOPERAMIDE LOPERAMIDE CAPSULE; ORAL 2MG 8/4/2005 HYDROCHLORIDE HYDROCHLORIDE BANNER PHARMACAPS MIDOL LIQUID GELS IBUPROFEN CAPSULE; ORAL 200MG 10/18/2002 BANNER PHARMACAPS NAPROXEN SODIUM NAPROXEN SODIUM CAPSULE; ORAL EQ 200MG BASE 2/17/2006 BAUSCH AND LOMB ALAWAY KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE 12/1/2006 OPHTHALMIC BAUSCH AND LOMB CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY 7/3/2001 BAUSCH AND LOMB OPCON-A NAPHAZOLINE SOLUTION/DROPS; 0.02675%;0.315% 6/8/1994 HYDROCHLORIDE; OPHTHALMIC PHENIRAMINE MALEATE BAYER ALEVE NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE 1/11/1994 BAYER ALEVE-D SINUS & COLD NAPROXEN SODIUM; TABLET, EXTENDED 200MG;120MG 11/29/1999 PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE BAYER FEMSTAT 3 BUTOCONAZOLE NITRATE CREAM; VAGINAL 2% 12/21/1995 BAYER HLTHCARE MYCELEX CLOTRIMAZOLE Solution; Topical 1% 1/15/1979 BAYER MYCELEX-7 CLOTRIMAZOLE TABLET; VAGINAL 100MG 2/27/1979 PHARMACEUTICALS BAYER MYCELEX-7 CLOTRIMAZOLE CREAM; VAGINAL 1% 2/16/1979 PHARMACEUTICALS BAYER MYCELEX-7 CLOTRIMAZOLE CREAM, TABLET; TOPICAL, 1%,100MG 6/23/1994 PHARMACEUTICALS COMBINATION PACK VAGINAL BECTON, DICKINSON CHLORHEXIDINE CHLORHEXIDINE SPONGE; TOPICAL 4% 10/24/1989 GLUCONATE GLUCONATE BECTON, DICKINSON E-Z SCRUB 201 POVIDONE-IODINE SPONGE; TOPICAL 20% 11/29/1985 BECTON, DICKINSON E-Z SCRUB 241 POVIDONE-IODINE SPONGE; TOPICAL 10% 1/7/1987

Source: FDA.gov 50 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date BLAIREX BRONCHO SALINE SODIUM CHLORIDE AEROSOL, METERED; 0.9% 9/3/1992 INHALATION BOEHRINGER INGELHEIM ZANTAC 150 RANITIDINE TABLET; ORAL EQ 150MG BASE 8/31/2004 HYDROCHLORIDE BOEHRINGER INGELHEIM ZANTAC 150 RANITIDINE TABLET; ORAL EQ 150MG BASE 8/31/2004 HYDROCHLORIDE BOEHRINGER INGELHEIM ZANTAC 75 RANITIDINE TABLET; ORAL EQ 75MG BASE 12/19/1995 HYDROCHLORIDE CADISTA PHARMS CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 6/15/2010 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CADISTA PHARMS CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 6/15/2010 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CADISTA PHARMS CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 6/15/2010 HYDROCHLORIDE HIVES HYDROCHLORIDE CADISTA PHARMS CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 6/15/2010 HYDROCHLORIDE HIVES HYDROCHLORIDE CARACO CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CARACO CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CARACO CETIRIZINE CETIRIZINE TABLET, CHEWABLE; ORAL 10MG 1/11/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CARACO CETIRIZINE CETIRIZINE TABLET, CHEWABLE; ORAL 5MG 1/11/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CARACO CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE CARACO CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE CARACO CETIRIZINE CETIRIZINE TABLET, CHEWABLE; ORAL 5MG 1/11/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF CARACO CETIRIZINE CETIRIZINE TABLET, CHEWABLE; ORAL 10MG 1/11/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF CAREFUSION CHLORAPREP ONE-STEP CHLORHEXIDINE SPONGE; TOPICAL 2%;70% (3ML) 7/14/2000 GLUCONATE; ISOPROPYL ALCOHOL CAREFUSION CHLORAPREP ONE-STEP CHLORHEXIDINE SPONGE; TOPICAL 2%;70% (10.5ML) 7/14/2000 GLUCONATE; ISOPROPYL ALCOHOL CAREFUSION CHLORAPREP ONE-STEP CHLORHEXIDINE SPONGE; TOPICAL 2%;70% (26ML) 7/14/2000 GLUCONATE; ISOPROPYL ALCOHOL CAREFUSION CHLORAPREP ONE-STEP CHLORHEXIDINE SPONGE; TOPICAL 2%;70% (1.5ML) 7/14/2000 FREPP GLUCONATE; ISOPROPYL ALCOHOL CAREFUSION CHLORAPREP ONE-STEP CHLORHEXIDINE SWAB; TOPICAL 2%;70% (0.67ML) 10/7/2002 SEPP GLUCONATE; ISOPROPYL ALCOHOL CAREFUSION CHLORAPREP SINGLE CHLORHEXIDINE SWAB; TOPICAL 2%;70% (1.75ML) 10/7/2002 SWABSTICK GLUCONATE; ISOPROPYL ALCOHOL CAREFUSION CHLORAPREP WITH TINT CHLORHEXIDINE SPONGE; TOPICAL 2%;70% (26ML) 7/14/2000 GLUCONATE; ISOPROPYL ALCOHOL CAREFUSION CHLORAPREP WITH TINT CHLORHEXIDINE SPONGE; TOPICAL 2%;70% (10.5ML) 7/14/2000 GLUCONATE; ISOPROPYL ALCOHOL

Source: FDA.gov 51 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date CAREFUSION CHLORAPREP WITH TINT CHLORHEXIDINE SPONGE; TOPICAL 2%;70% (3ML) 7/14/2000 GLUCONATE; ISOPROPYL ALCOHOL CHATTEM UNISOM DOXYLAMINE SUCCINATE TABLET; ORAL 25MG 10/18/1978 COLGATE PALMOLIVE COLGATE TOTAL SODIUM FLUORIDE; PASTE; DENTAL 0.24%;0.3% 7/11/1997 TRICLOSAN CONTRACT PHARMA CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CONTRACT PHARMA CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CONTRACT PHARMACAL CIMETIDINE CIMETIDINE TABLET; ORAL 200MG 6/19/1998 CONTRACT PHARMACAL CIMETIDINE CIMETIDINE TABLET; ORAL 200MG 6/19/1998 CONTRACT PHARMACAL IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 9/10/1987 CONTRACT PHARMACAL IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 9/10/1987 CONTRACT PHARMACAL IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 7/1/1988 CONTRACT PHARMACAL IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 2/25/1994 CONTRACT PHARMACAL IBUPROFEN IBUPROFEN CAPSULE; ORAL 200MG 7/6/1998 CONTRACT PHARMACAL IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 7/20/1998 CONTRACT PHARMACAL IBUPROFEN AND IBUPROFEN; TABLET; ORAL 200MG;30MG 4/8/2002 PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE CONTRACT PHARMACAL LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG 7/30/1993 HYDROCHLORIDE HYDROCHLORIDE CONTRACT PHARMACAL NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE 1/13/1997 CONTRACT PHARMACAL NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE 2/27/1997 CONTRACT PHARMACAL PROFEN IBUPROFEN TABLET; ORAL 200MG 10/15/1986 CONTRACT PHARMACAL RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 6/21/1999 HYDROCHLORIDE HYDROCHLORIDE CYPRESS PHARM CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 10/10/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY CYPRESS PHARM CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 10/10/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF DEXCEL PHARMA OMEPRAZOLE OMEPRAZOLE TABLET, DELAYED RELEASE; 20MG 12/4/2007 ORAL DR REDDYS LA IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 12/12/2001 DR REDDYS LABS INC IBUPROFEN IBUPROFEN TABLET; ORAL 100MG 11/20/2001 DR REDDYS LABS INC NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE 7/28/1998 DR REDDYS LABS INC NAPROXEN SODIUM NAPROXEN SODIUM; TABLET, EXTENDED EQ 220MG BASE;120MG 9/27/2006 AND PSEUDOEPHEDRINE PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE HYDROCHLORIDE DR REDDYS LABS LTD CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 1/15/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY DR REDDYS LABS LTD CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 1/15/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY DR REDDYS LABS LTD CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 1/15/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE DR REDDYS LABS LTD CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 1/15/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE DR REDDYS LABS LTD CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 3/30/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY DR REDDYS LABS LTD CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 3/30/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF DR REDDYS LABS LTD FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 8/17/2001

Source: FDA.gov 52 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date DR REDDYS LABS LTD FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG 9/25/2006 DR REDDYS LABS LTD IBUPROFEN IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID 7/10/2009 AND POTASSIUM SALT DR REDDYS LABS LTD IBUPROFEN AND DIPHENHYDRAMINE TABLET; ORAL 38MG;200MG 7/8/2009 DIPHENHYDRAMINE CITRATE; IBUPROFEN CITRATE DR REDDYS LABS LTD IBUPROFEN AND IBUPROFEN; TABLET; ORAL 200MG;30MG 8/14/2006 PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE DR REDDYS LABS LTD OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED EQ 20MG BASE 6/5/2009 MAGNESIUM MAGNESIUM RELEASE; ORAL DR REDDYS LABS LTD RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 3/28/2000 HYDROCHLORIDE HYDROCHLORIDE DR REDDYS LABS LTD RANITIDINE RANITIDINE TABLET; ORAL EQ 150MG BASE 8/31/2007 HYDROCHLORIDE HYDROCHLORIDE DURAMED PLAN B LEVONORGESTREL TABLET; ORAL 0.75MG 7/28/1999 DURAMED PLAN B ONE-STEP LEVONORGESTREL TABLET; ORAL 1.5MG 7/10/2009 ECOLAB CHG SCRUB CHLORHEXIDINE SOLUTION; TOPICAL 4% 7/22/1986 GLUCONATE ECOLAB CIDA-STAT CHLORHEXIDINE SOLUTION; TOPICAL 2% 7/22/1986 GLUCONATE FLEMING THYROSHIELD POTASSIUM IODIDE SOLUTION; ORAL 65MG/ML 1/12/2005 G AND W LABS ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG 2/9/1978 G AND W LABS ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG 2/9/1978 G AND W LABS ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 325MG 2/9/1978 G AND W LABS ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG 3/27/1992 G AND W LABS ACEPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 325MG 3/27/1992 G AND W LABS MICONAZOLE 7 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,100MG 3/26/2004 COMBINATION PACK TOPICAL, VAGINAL G AND W LABS MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 2% 2/22/1996 G AND W LABS MICONAZOLE NITRATE MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG 4/30/1997 GENPHARM FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 12/21/2001 GENPHARM RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 1/14/2000 HYDROCHLORIDE HYDROCHLORIDE GLAXOSMITHKLINE ABREVA DOCOSANOL CREAM; TOPICAL 10% 7/25/2000 GLAXOSMITHKLINE NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 1/13/1984 GLAXOSMITHKLINE NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 1/13/1984 GLAXOSMITHKLINE NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 6/8/1992 GLAXOSMITHKLINE NICORETTE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 6/8/1992 GLAXOSMITHKLINE NICORETTE (MINT) NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 1/13/1984 GLAXOSMITHKLINE NICORETTE (MINT) NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 6/8/1992 GLAXOSMITHKLINE TAGAMET HB CIMETIDINE TABLET; ORAL 200MG 6/19/1995 GLAXOSMITHKLINE ALLI ORLISTAT CAPSULE; ORAL 60MG 2/7/2007 CONS GLAXOSMITHKLINE COMMIT NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE 10/31/2002 CONS GLAXOSMITHKLINE COMMIT NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE 10/31/2002 CONS GLAXOSMITHKLINE NICORETTE NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE 5/18/2009 CONS GLAXOSMITHKLINE NICORETTE NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE 5/18/2009 CONS GRANULES INDIA IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 12/10/2010 GRIFFEN BIOSCRUB CHLORHEXIDINE SPONGE; TOPICAL 4% 3/31/1989 GLUCONATE GUARDIAN DRUG FOAMCOAT ALUMINUM HYDROXIDE; TABLET, CHEWABLE; ORAL 80MG;20MG 9/4/1987 MAGNESIUM TRISILICATE

Source: FDA.gov 53 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date HARMONY LABS THEROXIDIL MINOXIDIL SOLUTION; TOPICAL 5% 8/24/2004 HARMONY LABS THEROXIDIL MINOXIDIL SOLUTION; TOPICAL 2% 11/9/2007 HI TECH PHARMA LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML 11/17/1995 HYDROCHLORIDE HYDROCHLORIDE HI TECH PHARMA MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% 12/24/1996 HI TECH PHARMA MINOXIDIL (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% 12/24/1996 HISAMITSU SALONPAS MENTHOL; METHYL PATCH; TOPICAL 3%;10% 2/20/2008 SALICYLATE IMPAX LABS LORATADINE LORATADINE TABLET, ORALLY 10MG 9/29/2003 DISINTEGRATING; ORAL IMPAX LABS LORATADINE AND LORATADINE; TABLET, EXTENDED 10MG;240MG 3/4/2004 PSEUDOEPHEDRINE PSEUDOEPHEDRINE RELEASE; ORAL SULFATE SULFATE IMPAX LABS LORATADINE AND LORATADINE; TABLET, EXTENDED 5MG;120MG 1/30/2003 PSEUDOEPHEDRINE PSEUDOEPHEDRINE RELEASE; ORAL SULFATE SULFATE INSIGHT PHARMS NIX PERMETHRIN LOTION; TOPICAL 1% 5/2/1990 IVAX SUB TEVA PHARMS CETIRIZINE CETIRIZINE TABLET, EXTENDED 5MG;120MG 2/25/2008 HYDROCHLORIDE AND HYDROCHLORIDE; RELEASE; ORAL PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE IVAX SUB TEVA PHARMS CIMETIDINE CIMETIDINE TABLET; ORAL 200MG 6/16/1999 IVAX SUB TEVA PHARMS FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 7/26/2001 IVAX SUB TEVA PHARMS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 2/18/2009 IVAX SUB TEVA PHARMS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 2/18/2009 IVAX SUB TEVA PHARMS RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 1/14/2000 HYDROCHLORIDE HYDROCHLORIDE JOHNSON AND MEN’S ROGAINE MINOXIDIL AEROSOL, FOAM; 5% 1/20/2006 JOHNSON TOPICAL JOHNSON AND MONISTAT 1 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,1.2GM 6/29/2001 JOHNSON COMBINATION PACK TOPICAL, VAGINAL JOHNSON AND MONISTAT 3 MICONAZOLE NITRATE CREAM; VAGINAL 4% 3/30/1998 JOHNSON JOHNSON AND MONISTAT 3 MICONAZOLE NITRATE CREAM; TOPICAL, 2%,4% 2/2/2001 JOHNSON COMBINATION PACK VAGINAL JOHNSON AND MONISTAT 3 MICONAZOLE NITRATE CREAM; TOPICAL, 2%,4% 2/2/2001 JOHNSON COMBINATION PACK VAGINAL (PREFILLED) JOHNSON AND MONISTAT 7 MICONAZOLE NITRATE CREAM; VAGINAL 2% 1/30/1974 JOHNSON JOHNSON AND MONISTAT 7 MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG 3/15/1982 JOHNSON JOHNSON AND MONISTAT 7 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,100MG 4/26/1993 JOHNSON COMBINATION PACK TOPICAL, VAGINAL JOHNSON AND MONISTAT-3 MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,200MG 4/16/1996 JOHNSON COMBINATION PACK TOPICAL, VAGINAL JOHNSON AND ROGAINE (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% 8/17/1988 JOHNSON JOHNSON AND ROGAINE (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% 8/17/1988 JOHNSON JOHNSON AND ROGAINE EXTRA MINOXIDIL SOLUTION; TOPICAL 5% 11/14/1997 JOHNSON STRENGTH (FOR MEN) JOHNSON AND VISINE L.R. OXYMETAZOLINE SOLUTION/DROPS; 0.025% 3/31/1989 JOHNSON HYDROCHLORIDE OPHTHALMIC JOHNSON AND VISINE-A NAPHAZOLINE SOLUTION/DROPS; 0.025%;0.3% 1/31/1996 JOHNSON HYDROCHLORIDE; OPHTHALMIC PHENIRAMINE MALEATE KREMERS URBAN GLYCOLAX POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/PACKET 10/6/2009 PHARMS 3350 KREMERS URBAN GLYCOLAX POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/SCOOPFUL 10/6/2009 PHARMS 3350

Source: FDA.gov 54 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date LILLY HUMULIN 70/30 INSULIN RECOMBINANT INJECTABLE; INJECTION 30 UNITS/ML;70 UNITS/ML 4/25/1989 HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY HUMULIN 70/30 PEN INSULIN RECOMBINANT INJECTABLE; INJECTION 30 UNITS/ML;70 UNITS/ML 4/25/1989 HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY HUMULIN N INSULIN SUSP ISOPHANE INJECTABLE; INJECTION 100 UNITS/ML 10/28/1982 RECOMBINANT HUMAN LILLY HUMULIN R INSULIN RECOMBINANT INJECTABLE; INJECTION 100 UNITS/ML 10/28/1982 HUMAN LILLY HUMULIN R PEN INSULIN RECOMBINANT INJECTABLE; INJECTION 100 UNITS/ML 10/28/1982 HUMAN LNK DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE TABLET; ORAL 25MG 8/27/2004 LNK IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 3/1/1999 LNK IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 3/1/1999 LNK IBUPROFEN IBUPROFEN TABLET; ORAL 100MG 6/17/2004 LNK LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG 6/10/2003 HYDROCHLORIDE HYDROCHLORIDE L’OREAL USA ANTHELIOS 20 AVOBENZONE; CREAM; TOPICAL 2%;2%;10%;2% 10/5/2006 ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE L’OREAL USA ANTHELIOS 40 AVOBENZONE; CREAM; TOPICAL 2%;3%;10%;5% 3/31/2008 ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE L’OREAL USA ANTHELIOS 40 AVOBENZONE; CREAM; TOPICAL 2%;3%;10%;5% 3/31/2008 ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE L’OREAL USA ANTHELIOS SX AVOBENZONE; CREAM; TOPICAL 2%;2%;10% 7/21/2006 ECAMSULE; OCTOCRYLENE L’OREAL USA CAPITAL SOLEIL 15 AVOBENZONE; CREAM; TOPICAL 2%;3%;10% 10/2/2006 ECAMSULE; OCTOCRYLENE MARKSANS PHARMA IBUPROFEN IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID 6/26/2009 AND POTASSIUM SALT MARKSANS PHARMA IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 2/8/2011 MARKSANS PHARMA IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 2/1/2011 MCNEIL CHILDREN’S MOTRIN IBUPROFEN SUSPENSION; ORAL 100MG/5ML 6/16/1995 MCNEIL IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 3/30/1994 MCNEIL IMODIUM A-D EZ CHEWS LOPERAMIDE TABLET, CHEWABLE; ORAL 2MG 7/24/1997 HYDROCHLORIDE MCNEIL IMODIUM MULTI- LOPERAMIDE TABLET, CHEWABLE; ORAL 2MG;125MG 6/26/1997 SYMPTOM RELIEF HYDROCHLORIDE; SIMETHICONE MCNEIL MOTRIN IB IBUPROFEN TABLET; ORAL 200MG 5/18/1984 MCNEIL MOTRIN MIGRAINE PAIN IBUPROFEN TABLET; ORAL 200MG 5/18/1984 MCNEIL ZYRTEC-D 12 HOUR CETIRIZINE TABLET, EXTENDED 5MG;120MG 8/10/2001 HYDROCHLORIDE; RELEASE; ORAL PSEUDOEPHEDRINE HYDROCHLORIDE MCNEIL CONS CHILDREN’S MOTRIN IBUPROFEN TABLET, CHEWABLE; ORAL 50MG 11/15/1996 MCNEIL CONS CHILDREN’S MOTRIN IBUPROFEN SUSPENSION/DROPS; 40MG/ML 6/10/1996 ORAL MCNEIL CONS CHILDREN’S MOTRIN IBUPROFEN; SUSPENSION; ORAL 100MG/5ML;15MG/5ML 8/1/2000 COLD PSEUDOEPHEDRINE HYDROCHLORIDE MCNEIL CONS IMODIUM A-D LOPERAMIDE SOLUTION; ORAL 1MG/5ML 3/1/1988 HYDROCHLORIDE

Source: FDA.gov 55 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date MCNEIL CONS IMODIUM A-D LOPERAMIDE SUSPENSION; ORAL 1MG/7.5ML 3/1/1988 HYDROCHLORIDE MCNEIL CONS IMODIUM A-D LOPERAMIDE TABLET; ORAL 2MG 11/22/1989 HYDROCHLORIDE MCNEIL CONS IMODIUM MULTI- LOPERAMIDE TABLET; ORAL 2MG;125MG 11/30/2000 SYMPTOM RELIEF HYDROCHLORIDE; SIMETHICONE MCNEIL CONS JUNIOR STRENGTH IBUPROFEN TABLET, CHEWABLE; ORAL 100MG 11/15/1996 MOTRIN MCNEIL CONS JUNIOR STRENGTH IBUPROFEN TABLET; ORAL 100MG 6/10/1996 MOTRIN MCNEIL CONS NIZORAL A-D KETOCONAZOLE SHAMPOO; TOPICAL 1% 10/10/1997 MCNEIL CONS SINE-AID IB IBUPROFEN; TABLET; ORAL 200MG;30MG 12/31/1992 PSEUDOEPHEDRINE HYDROCHLORIDE MCNEIL CONS SUDAFED 12 HOUR PSEUDOEPHEDRINE TABLET, EXTENDED 120MG 10/31/1991 HYDROCHLORIDE RELEASE; ORAL MCNEIL CONS SUDAFED 24 HOUR PSEUDOEPHEDRINE TABLET, EXTENDED 240MG 12/15/1992 HYDROCHLORIDE RELEASE; ORAL MCNEIL CONS TYLENOL (CAPLET) ACETAMINOPHEN TABLET, EXTENDED 650MG 6/8/1994 RELEASE; ORAL MCNEIL CONS TYLENOL (GELTAB) ACETAMINOPHEN TABLET, EXTENDED 650MG 6/8/1994 RELEASE; ORAL MCNEIL CONSUMER CHILDREN’S ZYRTEC CETIRIZINE SYRUP; ORAL 5MG/5ML 11/16/2007 ALLERGY HYDROCHLORIDE MCNEIL CONSUMER CHILDREN’S ZYRTEC HIVES CETIRIZINE SYRUP; ORAL 5MG/5ML 11/16/2007 RELIEF HYDROCHLORIDE MCNEIL CONSUMER ZYRTEC ALLERGY CETIRIZINE TABLET; ORAL 5MG 12/8/1995 HYDROCHLORIDE MCNEIL CONSUMER ZYRTEC ALLERGY CETIRIZINE TABLET; ORAL 10MG 12/8/1995 HYDROCHLORIDE MCNEIL CONSUMER ZYRTEC ALLERGY CETIRIZINE TABLET, ORALLY 10MG 9/3/2010 HYDROCHLORIDE DISINTEGRATING; ORAL MCNEIL CONSUMER ZYRTEC HIVES RELIEF CETIRIZINE TABLET; ORAL 5MG 12/8/1995 HYDROCHLORIDE MCNEIL CONSUMER ZYRTEC HIVES RELIEF CETIRIZINE TABLET; ORAL 10MG 12/8/1995 HYDROCHLORIDE MERCK SHARP DOHME PEPCID AC FAMOTIDINE TABLET; ORAL 10MG 4/28/1995 MERCK SHARP DOHME PEPCID AC FAMOTIDINE TABLET; ORAL 20MG 4/28/1995 MERCK SHARP DOHME PEPCID AC FAMOTIDINE TABLET, CHEWABLE; ORAL 20MG 9/24/1998 MERCK SHARP DOHME PEPCID AC (GELTAB) FAMOTIDINE TABLET; ORAL 10MG 8/5/1999 MERCK SHARP DOHME PEPCID COMPLETE CALCIUM CARBONATE; TABLET, CHEWABLE; ORAL 800MG;10MG;165MG 10/16/2000 FAMOTIDINE; MAGNESIUM HYDROXIDE MYLAN CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY MYLAN CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY MYLAN CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE MYLAN CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE MYLAN LORATADINE LORATADINE TABLET; ORAL 10MG 11/7/2008 MYLAN LORATADINE LORATADINE TABLET; ORAL 10MG 8/20/2003 MYLAN POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/PACKET 10/6/2009 3350 3350 MYLAN POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/SCOOPFUL 10/6/2009 3350 3350

Source: FDA.gov 56 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date NEXGEN PHARMA POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/SCOOPFUL 10/7/2009 3350 3350 NOVARTIS EXCEDRIN (MIGRAINE) ACETAMINOPHEN; TABLET; ORAL 250MG;250MG;65MG 1/14/1998 ASPIRIN; CAFFEINE NOVARTIS HABITROL NICOTINE FILM, EXTENDED RELEASE; 7MG/24HR 11/27/1991 TRANSDERMAL NOVARTIS HABITROL NICOTINE FILM, EXTENDED RELEASE; 14MG/24HR 11/27/1991 TRANSDERMAL NOVARTIS HABITROL NICOTINE FILM, EXTENDED RELEASE; 21MG/24HR 11/27/1991 TRANSDERMAL NOVARTIS LAMISIL TERBINAFINE CREAM; TOPICAL 1% 3/9/1999 HYDROCHLORIDE NOVARTIS LAMISIL AT TERBINAFINE SOLUTION; TOPICAL 1% 3/17/2000 HYDROCHLORIDE NOVARTIS LAMISIL AT TERBINAFINE SPRAY; TOPICAL 1% 3/17/2000 HYDROCHLORIDE NOVARTIS LAMISIL AT TERBINAFINE GEL; TOPICAL 1% 7/24/2006 NOVARTIS NEXCEDE KETOPROFEN FILM; ORAL 12.5MG 11/25/2009 NOVARTIS PREVACID 24 HR LANSOPRAZOLE CAPSULE, DELAYED REL 15MG 5/18/2009 PELLETS; ORAL NOVARTIS TAVIST ALLERGY/SINUS/ ACETAMINOPHEN; TABLET; ORAL 500MG;EQ 0.25MG 3/1/2001 HEADACHE CLEMASTINE FUMARATE; BASE;30MG PSEUDOEPHEDRINE HYDROCHLORIDE NOVARTIS TAVIST-1 CLEMASTINE FUMARATE TABLET; ORAL 1.34MG 8/21/1992 NOVARTIS THRIVE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 6/19/2007 NOVARTIS THRIVE NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 6/19/2007 NOVARTIS VAGISTAT-1 TIOCONAZOLE OINTMENT; VAGINAL 6.5% 2/11/1997 NOVARTIS ZADITOR KETOTIFEN FUMARATE SOLUTION/DROPS; EQ 0.025% BASE 7/2/1999 OPHTHALMIC NOVEL LABS INC POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/SCOOPFUL 10/6/2009 3350 3350 NOVEX MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% 4/29/1998 NOVEX MINOXIDIL (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% 4/29/1998 NOVEX MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% 10/1/2001 STRENGTH (FOR MEN) NOVO NORDISK INC NOVOLIN 70/30 INSULIN RECOMBINANT INJECTABLE; INJECTION 30 UNITS/ML;70 UNITS/ML 6/25/1991 HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC NOVOLIN N INSULIN SUSP ISOPHANE INJECTABLE; INJECTION 100 UNITS/ML 7/1/1991 RECOMBINANT HUMAN NOVO NORDISK INC NOVOLIN R INSULIN RECOMBINANT INJECTABLE; INJECTION 100 UNITS/ML 6/25/1991 HUMAN OHM IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 7/15/1986 OHM LABS ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED 650MG 3/19/2002 RELEASE; ORAL OHM LABS IBUPROHM IBUPROFEN TABLET; ORAL 200MG 12/1/1986 OHM LABS IBUPROHM COLD AND IBUPROFEN; TABLET; ORAL 200MG;30MG 4/17/2001 SINUS PSEUDOEPHEDRINE HYDROCHLORIDE OHM LABS LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG 12/10/1992 HYDROCHLORIDE HYDROCHLORIDE ORCHID HLTHCARE CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 2/19/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY ORCHID HLTHCARE CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 2/19/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY ORCHID HLTHCARE CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 2/19/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE

Source: FDA.gov 57 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date ORCHID HLTHCARE CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 2/19/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE PADDOCK POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/SCOOPFUL 10/15/2009 3350 3350 PAR PHARM IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 10/18/1985 PAR PHARM IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 10/2/1987 PERRIGO ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED 650MG 2/25/2000 RELEASE; ORAL PERRIGO ACETAMINOPHEN, ACETAMINOPHEN; TABLET; ORAL 250MG;250MG;65MG 11/26/2001 ASPIRIN AND CAFFEINE ASPIRIN; CAFFEINE PERRIGO CHILDREN’S IBUPROFEN IBUPROFEN SUSPENSION; ORAL 100MG/5ML 12/22/1998 PERRIGO CIMETIDINE CIMETIDINE TABLET; ORAL 200MG 10/29/1998 PERRIGO CLEMASTINE FUMARATE CLEMASTINE FUMARATE TABLET; ORAL 1.34MG 11/22/1995 PERRIGO CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY 12/12/2001 PERRIGO DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE TABLET; ORAL 25MG 9/18/1996 PERRIGO FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 3/18/2005 PERRIGO FAMOTIDINE FAMOTIDINE TABLET, CHEWABLE; ORAL 10MG 8/22/2003 PERRIGO FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG 9/25/2006 PERRIGO IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 12/8/1987 PERRIGO IBUPROFEN IBUPROFEN SUSPENSION/DROPS; 40MG/ML 12/16/1998 ORAL PERRIGO IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 3/14/2002 PERRIGO IBUPROFEN IBUPROFEN TABLET, CHEWABLE; ORAL 50MG 1/16/2004 PERRIGO IBUPROFEN IBUPROFEN TABLET, CHEWABLE; ORAL 100MG 1/16/2004 PERRIGO IBUPROFEN AND IBUPROFEN; SUSPENSION; ORAL 100MG/5ML;15MG/5ML 11/5/2003 PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE PERRIGO JUNIOR STRENGTH IBUPROFEN TABLET; ORAL 100MG 4/22/1999 IBUPROFEN PERRIGO LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML 1/21/1992 HYDROCHLORIDE HYDROCHLORIDE PERRIGO LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG 1/6/2000 HYDROCHLORIDE HYDROCHLORIDE PERRIGO LOPERAMIDE LOPERAMIDE TABLET, CHEWABLE; ORAL 2MG;125MG 8/30/2002 HYDROCHLORIDE AND HYDROCHLORIDE; SIMETHICONE SIMETHICONE PERRIGO LORATADINE LORATADINE SYRUP; ORAL 1MG/ML 8/20/2004 PERRIGO LORATADINE LORATADINE TABLET; ORAL 10MG 6/25/2004 PERRIGO MICONAZOLE 3 MICONAZOLE NITRATE CREAM; TOPICAL, 2%,4% 3/30/2004 COMBINATION PACK VAGINAL PERRIGO MICONAZOLE NITRATE MICONAZOLE NITRATE SUPPOSITORY; VAGINAL 100MG 3/20/1997 PERRIGO MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 2% 5/15/1997 PERRIGO MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,200MG 4/20/1999 COMBINATION PACK TOPICAL, VAGINAL PERRIGO MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% 7/30/1999 PERRIGO MINOXIDIL (FOR WOMEN) MINOXIDIL SOLUTION; TOPICAL 2% 7/30/1999 PERRIGO MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% 6/13/2001 STRENGTH (FOR MEN) PERRIGO NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE 1/13/1997 PERRIGO NAPROXEN SODIUM NAPROXEN SODIUM; TABLET, EXTENDED EQ 200MG BASE;120MG 3/17/2004 AND PSEUDOEPHEDRINE PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE HYDROCHLORIDE PERRIGO NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 9/16/2004 PERRIGO NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 9/16/2004 PERRIGO NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 9/16/2004 PERRIGO NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 9/16/2004

Source: FDA.gov 58 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date PERRIGO NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 9/16/2004 PERRIGO NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 9/16/2004 PERRIGO PSEUDOEPHEDRINE PSEUDOEPHEDRINE TABLET, EXTENDED 120MG 2/26/1999 HYDROCHLORIDE HYDROCHLORIDE RELEASE; ORAL PERRIGO RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 8/30/2002 HYDROCHLORIDE HYDROCHLORIDE PERRIGO TAB-PROFEN IBUPROFEN TABLET; ORAL 200MG 12/8/1987 PERRIGO TIOCONAZOLE TIOCONAZOLE OINTMENT; VAGINAL 6.5% 11/21/2001 PERRIGO NEW YORK ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG 4/6/1987 PERRIGO NEW YORK ACETAMINOPHEN ACETAMINOPHEN SUPPOSITORY; RECTAL 650MG 12/1/1986 PERRIGO NEW YORK MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% 3/15/2002 STRENGTH (FOR MEN) PERRIGO NEW YORK PERMETHRIN PERMETHRIN LOTION; TOPICAL 1% 12/20/2001 PERRIGO R&D CALCIUM CARBONATE, CALCIUM CARBONATE; TABLET, CHEWABLE; ORAL 800MG;10MG;165MG 2/6/2008 FAMOTIDINE AND FAMOTIDINE; MAGNESIUM MAGNESIUM HYDROXIDE HYDROXIDE PERRIGO R&D CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY PERRIGO R&D CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY PERRIGO R&D CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE PERRIGO R&D CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE PERRIGO R&D CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 4/9/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY PERRIGO R&D CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 4/9/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF PERRIGO R&D IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 6/21/2005 PERRIGO R&D IBUPROFEN AND DIPHENHYDRAMINE TABLET; ORAL 38MG;200MG 12/22/2008 DIPHENHYDRAMINE CITRATE; IBUPROFEN CITRATE PERRIGO R&D LEVONORGESTREL LEVONORGESTREL TABLET; ORAL 0.75MG 12/30/2010 PERRIGO R&D LEVONORGESTREL LEVONORGESTREL TABLET; ORAL 0.75MG 12/30/2010 PERRIGO R&D MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM, SUPPOSITORY; 2%,1.2GM 6/2/2010 TOPICAL, VAGINAL PERRIGO R&D MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; TOPICAL, 2% 6/2/2010 VAGINAL PERRIGO R&D MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 4% 1/15/2010 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE 1/31/2006 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE 1/31/2006 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 10/30/2006 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 10/30/2006 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 5/24/2007 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 5/24/2007 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 4/23/2008 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 4/23/2008 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE 7/10/2009 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE 7/10/2009 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 2MG BASE 7/10/2009 PERRIGO R&D NICOTINE POLACRILEX NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL EQ 4MG BASE 7/10/2009 PERRIGO R&D POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/PACKET 10/6/2009 3350 3350

Source: FDA.gov 59 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date PERRIGO R&D POLYETHYLENE GLYCOL POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/SCOOPFUL 10/6/2009 3350 3350 PFIZER CHILDREN’S ZYRTEC CETIRIZINE TABLET, CHEWABLE; ORAL 5MG 3/16/2004 ALLERGY HYDROCHLORIDE PFIZER CHILDREN’S ZYRTEC CETIRIZINE TABLET, CHEWABLE; ORAL 10MG 3/16/2004 ALLERGY HYDROCHLORIDE PFIZER CHILDREN’S ZYRTEC HIVES CETIRIZINE TABLET, CHEWABLE; ORAL 5MG 3/16/2004 RELIEF HYDROCHLORIDE PFIZER CHILDREN’S ZYRTEC HIVES CETIRIZINE TABLET, CHEWABLE; ORAL 10MG 3/16/2004 RELIEF HYDROCHLORIDE PFIZER RID MOUSSE PIPERONYL BUTOXIDE; AEROSOL; TOPICAL 4%;EQ 0.33% BASE 3/7/2000 PYRETHRINS PHARMASEAL PHARMASEAL SCRUB CHLORHEXIDINE SPONGE; TOPICAL 4% 12/2/1988 CARE GLUCONATE POLYMEDICA NEOPAP ACETAMINOPHEN SUPPOSITORY; RECTAL 120MG 11/7/1968 QPHARMA CROMOLYN SODIUM CROMOLYN SODIUM SPRAY, METERED; NASAL 5.2MG/SPRAY 9/7/2007 RANBAXY ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED 650MG 11/18/2009 RELEASE; ORAL RANBAXY CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY RANBAXY CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY RANBAXY CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE RANBAXY CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HIVES HYDROCHLORIDE RANBAXY CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 4/24/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY RANBAXY CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 4/24/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF RANBAXY FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 11/17/2009 RANBAXY FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG 11/17/2009 RANBAXY LOPERAMIDE LOPERAMIDE TABLET; ORAL 2MG;125MG 9/6/2006 HYDROCHLORIDE AND HYDROCHLORIDE; SIMETHICONE SIMETHICONE RANBAXY LORATADINE LORATADINE TABLET; ORAL 10MG 8/18/2003 RANBAXY LORATADINE LORATADINE SYRUP; ORAL 1MG/ML 8/20/2004 RANBAXY LORATADINE AND LORATADINE; TABLET, EXTENDED 10MG;240MG 9/22/2004 PSEUDOEPHEDRINE PSEUDOEPHEDRINE RELEASE; ORAL SULFATE SULFATE RANBAXY LORATADINE REDIDOSE LORATADINE TABLET, ORALLY 10MG 4/11/2007 DISINTEGRATING; ORAL RANBAXY PSEUDOEPHEDRINE PSEUDOEPHEDRINE TABLET, EXTENDED 120MG 9/28/2005 HYDROCHLORIDE HYDROCHLORIDE RELEASE; ORAL RECIP THYROSAFE POTASSIUM IODIDE TABLET; ORAL 65MG 9/10/2002 RECKITT BENCKISER DELSYM DEXTROMETHORPHAN SUSPENSION, EXTENDED EQ 30MG HBR/5ML 10/8/1982 POLISTIREX RELEASE; ORAL RECKITT BENCKISER MUCINEX GUAIFENESIN TABLET, EXTENDED 600MG 7/12/2002 RELEASE; ORAL RECKITT BENCKISER MUCINEX GUAIFENESIN TABLET, EXTENDED 1.2GM 7/12/2002 RELEASE; ORAL RECKITT BENCKISER MUCINEX D GUAIFENESIN; TABLET, EXTENDED 600MG;60MG 6/22/2004 PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE RECKITT BENCKISER MUCINEX D GUAIFENESIN; TABLET, EXTENDED 1.2GM;120MG 6/22/2004 PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE

Source: FDA.gov 60 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date RECKITT BENCKISER MUCINEX DM DEXTROMETHORPHAN TABLET, EXTENDED 60MG;1.2GM 4/29/2004 HYDROBROMIDE; RELEASE; ORAL GUAIFENESIN RECKITT BENCKISER MUCINEX DM DEXTROMETHORPHAN TABLET, EXTENDED 30MG;600MG 4/29/2004 HYDROBROMIDE; RELEASE; ORAL GUAIFENESIN REGENT HIBICLENS CHLORHEXIDINE SOLUTION; TOPICAL 4% 9/17/1976 GLUCONATE REGENT HIBISTAT CHLORHEXIDINE SOLUTION; TOPICAL 0.5% 5/23/1980 GLUCONATE ROXANE LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML 4/30/1992 HYDROCHLORIDE HYDROCHLORIDE SAGE PRODS CHLORHEXIDINE CHLORHEXIDINE CLOTH; TOPICAL 2% 4/25/2005 GLUCONATE GLUCONATE SANDOZ CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY SANDOZ CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/27/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY SANDOZ CETIRIZINE CETIRIZINE TABLET, CHEWABLE; ORAL 5MG 2/14/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY SANDOZ CETIRIZINE CETIRIZINE TABLET, CHEWABLE; ORAL 10MG 2/14/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY SANDOZ CETIRIZINE CETIRIZINE TABLET, EXTENDED 5MG;120MG 3/5/2008 HYDROCHLORIDE AND HYDROCHLORIDE; RELEASE; ORAL PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCHLORIDE SANDOZ CLEMASTINE FUMARATE CLEMASTINE FUMARATE TABLET; ORAL 1.34MG 10/31/1993 SANDOZ FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 10/21/2002 SANDOZ LORATADINE LORATADINE TABLET; ORAL 10MG 1/21/2003 SANDOZ NAPROXEN SODIUM NAPROXEN SODIUM TABLET; ORAL EQ 200MG BASE 1/13/1997 SANOFI-AVENTIS US ALLEGRA ALLERGY; FEXOFENADINE SUSPENSION; ORAL 30MG/5ML 1/24/2011 ALLEGRA HIVES HYDROCHLORIDE SANOFI-AVENTIS US GAVISCON ALUMINUM HYDROXIDE; TABLET, CHEWABLE; ORAL 80MG;20MG 12/9/1983 MAGNESIUM TRISILICATE SANOFI-AVENTIS US GAVISCON ALUMINUM HYDROXIDE; TABLET, CHEWABLE; ORAL 160MG;40MG 12/9/1983 MAGNESIUM TRISILICATE SANOFI-AVENTIS US NICODERM CQ NICOTINE FILM, EXTENDED RELEASE; 21MG/24HR 11/7/1991 TRANSDERMAL SANOFI-AVENTIS US NICODERM CQ NICOTINE FILM, EXTENDED RELEASE; 14MG/24HR 11/7/1991 TRANSDERMAL SANOFI-AVENTIS US NICODERM CQ NICOTINE FILM, EXTENDED RELEASE; 7MG/24HR 11/7/1991 TRANSDERMAL SCHERING-PLOUGH AFRINOL PSEUDOEPHEDRINE TABLET, EXTENDED 120MG 10/30/1980 SULFATE RELEASE; ORAL SCHERING-PLOUGH CHILDREN’S CLARITIN LORATADINE TABLET, CHEWABLE; ORAL 5MG 8/23/2006 SCHERING-PLOUGH CHLOR-TRIMETON CHLORPHENIRAMINE TABLET, EXTENDED 12MG 8/15/1950 MALEATE RELEASE; ORAL SCHERING-PLOUGH CHLOR-TRIMETON CHLORPHENIRAMINE TABLET, EXTENDED 8MG;120MG 3/31/1981 MALEATE; RELEASE; ORAL PSEUDOEPHEDRINE SULFATE SCHERING-PLOUGH CLARITIN LORATADINE TABLET; ORAL 10MG 4/12/1993 SCHERING-PLOUGH CLARITIN LORATADINE SYRUP; ORAL 1MG/ML 10/10/1996 SCHERING-PLOUGH CLARITIN LORATADINE CAPSULE; ORAL 10MG 6/16/2008 SCHERING-PLOUGH CLARITIN HIVES RELIEF LORATADINE TABLET; ORAL 10MG 4/12/1993 SCHERING-PLOUGH CLARITIN HIVES RELIEF LORATADINE TABLET, ORALLY 10MG 12/23/1996 REDITAB DISINTEGRATING; ORAL

Source: FDA.gov 61 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date SCHERING-PLOUGH CLARITIN REDITABS LORATADINE TABLET, ORALLY 10MG 12/23/1996 DISINTEGRATING; ORAL SCHERING-PLOUGH CLARITIN REDITABS LORATADINE TABLET, ORALLY 5MG 12/12/2006 DISINTEGRATING; ORAL SCHERING-PLOUGH CLARITIN-D LORATADINE; TABLET, EXTENDED 5MG;120MG 11/14/1994 PSEUDOEPHEDRINE RELEASE; ORAL SULFATE SCHERING-PLOUGH CLARITIN-D 24 HOUR LORATADINE; TABLET, EXTENDED 10MG;240MG 8/23/1996 PSEUDOEPHEDRINE RELEASE; ORAL SULFATE SCHERING-PLOUGH DISOPHROL DEXBROMPHENIRAMINE TABLET, EXTENDED 6MG;120MG 10/18/1963 MALEATE; RELEASE; ORAL PSEUDOEPHEDRINE SULFATE SCHERING-PLOUGH DRIXORAL DEXBROMPHENIRAMINE TABLET, EXTENDED 6MG;120MG 10/18/1963 MALEATE; RELEASE; ORAL PSEUDOEPHEDRINE SULFATE SCHERING-PLOUGH DRIXORAL PLUS ACETAMINOPHEN; TABLET, EXTENDED 500MG;3MG;60MG 5/22/1987 DEXBROMPHENIRAMINE RELEASE; ORAL MALEATE; PSEUDOEPHEDRINE SULFATE SCHERING-PLOUGH GYNE-LOTRIMIN CLOTRIMAZOLE TABLET; VAGINAL 100MG 3/24/1976 SCHERING-PLOUGH GYNE-LOTRIMIN CLOTRIMAZOLE CREAM; VAGINAL 1% 11/8/1978 SCHERING-PLOUGH GYNE-LOTRIMIN 3 CLOTRIMAZOLE TABLET; VAGINAL 200MG 7/29/1996 SCHERING-PLOUGH GYNE-LOTRIMIN 3 CLOTRIMAZOLE CREAM; VAGINAL 2% 11/24/1998 SCHERING-PLOUGH GYNE-LOTRIMIN 3 CLOTRIMAZOLE CREAM, TABLET; TOPICAL, 1%,200MG 7/29/1996 COMBINATION PACK VAGINAL SCHERING-PLOUGH GYNE-LOTRIMIN CLOTRIMAZOLE CREAM, TABLET; TOPICAL, 1%,100MG 4/26/1993 COMBINATION PACK VAGINAL SCHERING-PLOUGH LOTRIMIN AF CLOTRIMAZOLE Cream; Topical 1% 10/27/1989 SCHERING-PLOUGH LOTRIMIN AF CLOTRIMAZOLE Lotion; Topical 1% 10/27/1989 SCHERING-PLOUGH LOTRIMIN AF CLOTRIMAZOLE Solution; Topical 1% 10/27/1989 SCHERING-PLOUGH LOTRIMIN ULTRA BUTENAFINE CREAM; TOPICAL 1% 12/7/2001 HYDROCHLORIDE SCHERING-PLOUGH MIRALAX POLYETHYLENE GLYCOL FOR SOLUTION; ORAL 17GM/SCOOPFUL 10/6/2006 3350 SCHERING-PLOUGH OCUCLEAR OXYMETAZOLINE SOLUTION/DROPS; 0.025% 5/30/1986 HYDROCHLORIDE OPHTHALMIC SCHERING-PLOUGH SHADE UVAGUARD AVOBENZONE; LOTION; TOPICAL 3%;7.5%;3% 12/7/1992 OCTINOXATE; OXYBENZONE SCHERING-PLOUGH ZEGERID OTC OMEPRAZOLE; SODIUM CAPSULE; ORAL 20MG;1.1GM 12/1/2009 BICARBONATE SILARX LORATADINE LORATADINE SYRUP; ORAL 1MG/ML 6/29/2006 SOAPCO BRIAN CARE CHLORHEXIDINE SOLUTION; TOPICAL 4% 12/17/1987 GLUCONATE SOLUMED CHLORASCRUB MAXI CHLORHEXIDINE SWAB; TOPICAL 3.15%;70% (5.1ML) 6/3/2005 SWABSTICK GLUCONATE; ISOPROPYL ALCOHOL SOLUMED CHLORASCRUB SWAB CHLORHEXIDINE SWAB; TOPICAL 3.15%;70% (1ML) 6/3/2005 GLUCONATE; ISOPROPYL ALCOHOL SOLUMED CHLORASCRUB CHLORHEXIDINE SWAB; TOPICAL 3.15%;70% (1.6ML) 6/3/2005 SWABSTICK GLUCONATE; ISOPROPYL ALCOHOL STAND HOMEOPATH IVY BLOCK BENTOQUATAM LOTION; TOPICAL 5% 8/26/1996 TARO CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 7/22/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY

Source: FDA.gov 62 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date TARO CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 7/22/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY TARO CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 7/22/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF TARO CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 7/22/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF TARO CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 4/22/2008 HYDROCHLORIDE HYDROCHLORIDE ALLERGY TARO CHILDREN’S CETIRIZINE CETIRIZINE SYRUP; ORAL 5MG/5ML 4/22/2008 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF TARO CLOTRIMAZOLE CLOTRIMAZOLE CREAM; VAGINAL 1% 12/4/1995 TARO LORATADINE LORATADINE SUSPENSION; ORAL 1MG/ML 10/4/2005 TARO LORATADINE LORATADINE SYRUP; ORAL 1MG/ML 8/20/2004 TARO MICONAZOLE 3 MICONAZOLE NITRATE CREAM; VAGINAL 4% 3/2/2005 TARO MICONAZOLE NITRATE MICONAZOLE NITRATE CREAM; VAGINAL 2% 1/13/1997 TARO TERBINAFINE TERBINAFINE CREAM; TOPICAL 1% 7/2/2007 HYDROCHLORIDE HYDROCHLORIDE TARO TRIVAGIZOLE 3 CLOTRIMAZOLE CREAM; VAGINAL 2% 4/12/2000 TEVA FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 5/31/2001 TEVA LORATADINE LORATADINE SYRUP; ORAL 1MG/ML 11/7/2003 TORPHARM RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 5/4/2000 HYDROCHLORIDE HYDROCHLORIDE TORRENT PHARMS LLC CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 4/15/2010 HYDROCHLORIDE HYDROCHLORIDE ALLERGY TORRENT PHARMS LLC CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 4/15/2010 HYDROCHLORIDE HYDROCHLORIDE ALLERGY TORRENT PHARMS LLC CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 4/15/2010 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF TORRENT PHARMS LLC CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 4/15/2010 HYDROCHLORIDE HIVES HYDROCHLORIDE RELIEF TRIS PHARMA INC IBUPROFEN IBUPROFEN SUSPENSION/DROPS; 40MG/ML 8/31/2009 ORAL UNICHEM CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 6/26/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY UNICHEM CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 6/26/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY UNICHEM CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 6/26/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE UNICHEM CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 6/26/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE UNIQUE PHARM LABS CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 8/26/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY UNIQUE PHARM LABS CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 8/26/2009 HYDROCHLORIDE HYDROCHLORIDE ALLERGY UNIQUE PHARM LABS CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 8/26/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE UNIQUE PHARM LABS CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 8/26/2009 HYDROCHLORIDE HIVES HYDROCHLORIDE VINTAGE PHARMS IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 4/1/1987 VINTAGE PHARMS IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 2/2/1988

Source: FDA.gov 63 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date WATSON LABS CIMETIDINE CIMETIDINE TABLET; ORAL 200MG 7/29/1999 WATSON LABS FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 11/28/2001 WATSON LABS IBUPROFEN IBUPROFEN TABLET; ORAL 200MG 3/5/1986 WATSON LABS LEVONORGESTREL LEVONORGESTREL TABLET; ORAL 0.75MG 8/28/2009 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 3/15/1999 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 3/19/1999 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 7/29/2004 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 7/29/2004 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 12/29/2008 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 12/29/2008 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 7/8/2009 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 7/8/2009 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 2MG BASE 7/8/2009 WATSON LABS NICOTINE POLACRILEX NICOTINE POLACRILEX GUM, CHEWING; BUCCAL EQ 4MG BASE 7/8/2009 WATSON LABS RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 1/14/2000 HYDROCHLORIDE HYDROCHLORIDE WATSON LABS FLORIDA LORATADINE LORATADINE TABLET, ORALLY 10MG 11/3/2003 DISINTEGRATING; ORAL WATSON LABS FLORIDA LORATADINE AND LORATADINE; TABLET, EXTENDED 10MG;240MG 2/21/2003 PSEUDOEPHEDRINE PSEUDOEPHEDRINE RELEASE; ORAL SULFATE SULFATE WATSON LABS FLORIDA LORATADINE AND LORATADINE; TABLET, EXTENDED 5MG;120MG 1/28/2004 PSEUDOEPHEDRINE PSEUDOEPHEDRINE RELEASE; ORAL SULFATE SULFATE WOCKHARDT CETIRIZINE CETIRIZINE TABLET; ORAL 5MG 12/28/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY WOCKHARDT CETIRIZINE CETIRIZINE TABLET; ORAL 10MG 12/28/2007 HYDROCHLORIDE HYDROCHLORIDE ALLERGY WOCKHARDT FAMOTIDINE FAMOTIDINE TABLET; ORAL 10MG 3/7/2005 WOCKHARDT FAMOTIDINE FAMOTIDINE TABLET; ORAL 20MG 8/4/2010 WOCKHARDT LOPERAMIDE LOPERAMIDE SOLUTION; ORAL 1MG/5ML 8/28/1997 HYDROCHLORIDE HYDROCHLORIDE WOCKHARDT LORATADINE LORATADINE SYRUP; ORAL 1MG/ML 8/20/2004 WOCKHARDT MINOXIDIL (FOR MEN) MINOXIDIL SOLUTION; TOPICAL 2% 2/28/1997 WOCKHARDT MINOXIDIL EXTRA MINOXIDIL SOLUTION; TOPICAL 5% 2/28/2003 STRENGTH (FOR MEN) WOCKHARDT RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 2/24/2006 HYDROCHLORIDE HYDROCHLORIDE WOCKHARDT RANITIDINE RANITIDINE TABLET; ORAL EQ 150MG BASE 11/26/2007 HYDROCHLORIDE HYDROCHLORIDE WOCKHARDT RANITIDINE RANITIDINE TABLET; ORAL EQ 75MG BASE 7/31/2008 HYDROCHLORIDE HYDROCHLORIDE WYETH CONS ADVIL IBUPROFEN TABLET; ORAL 200MG 5/18/1984 WYETH CONS ADVIL ALLERGY SINUS CHLORPHENIRAMINE TABLET; ORAL 2MG;200MG;30MG 12/19/2002 MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE WYETH CONS ADVIL COLD AND SINUS IBUPROFEN; TABLET; ORAL 200MG;30MG 9/19/1989 PSEUDOEPHEDRINE HYDROCHLORIDE WYETH CONS ADVIL COLD AND SINUS IBUPROFEN; CAPSULE; ORAL EQ 200MG FREE ACID 5/30/2002 PSEUDOEPHEDRINE AND POTASSIUM HYDROCHLORIDE SALT;30MG WYETH CONS ADVIL CONGESTION IBUPROFEN; TABLET; ORAL 200MG;10MG 5/27/2010 RELIEF PHENYLEPHRINE HYDROCHLORIDE

Source: FDA.gov 64 FDA OTC Approvals On The Market: By Company

Sponsor Applicant Drug Name Active Ingredient Form Dosage Action Date WYETH CONS ADVIL LIQUI-GELS IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID 4/20/1995 AND POTASSIUM SALT WYETH CONS ADVIL MIGRAINE LIQUI- IBUPROFEN CAPSULE; ORAL EQ 200MG FREE ACID 4/20/1995 GELS AND POTASSIUM SALT WYETH CONS ADVIL PM DIPHENHYDRAMINE CAPSULE; ORAL 25MG;EQ 200MG FREE 12/21/2005 HYDROCHLORIDE; ACID AND POTASSIUM IBUPROFEN SALT WYETH CONS ADVIL PM DIPHENHYDRAMINE TABLET; ORAL 38MG;200MG 12/21/2005 CITRATE; IBUPROFEN WYETH CONS ALAVERT LORATADINE TABLET, ORALLY 10MG 12/19/2002 DISINTEGRATING; ORAL WYETH CONS AXID AR NIZATIDINE TABLET; ORAL 75MG 5/9/1996 WYETH CONS CHILDREN’S ADVIL IBUPROFEN SUSPENSION; ORAL 100MG/5ML 6/27/1996 WYETH CONS CHILDREN’S ADVIL IBUPROFEN TABLET, CHEWABLE; ORAL 50MG 12/18/1998 WYETH CONS CHILDREN’S ADVIL CHLORPHENIRAMINE SUSPENSION; ORAL 1MG/5ML; 100MG/5ML; 2/24/2004 ALLERGY SINUS MALEATE; IBUPROFEN; 15MG/5ML PSEUDOEPHEDRINE HYDROCHLORIDE WYETH CONS CHILDREN’S ADVIL COLD IBUPROFEN; SUSPENSION; ORAL 100MG/5ML;15MG/5ML 4/18/2002 PSEUDOEPHEDRINE HYDROCHLORIDE WYETH CONS CHILDREN’S ADVIL- IBUPROFEN SUSPENSION; ORAL 100MG/5ML 6/27/1996 FLAVORED WYETH CONS JUNIOR STRENGTH ADVIL IBUPROFEN TABLET; ORAL 100MG 12/13/1996 WYETH CONS JUNIOR STRENGTH ADVIL IBUPROFEN TABLET, CHEWABLE; ORAL 100MG 12/18/1998 WYETH CONS LORATADINE LORATADINE TABLET, ORALLY 10MG 2/10/2003 DISINTEGRATING; ORAL WYETH CONS PEDIATRIC ADVIL IBUPROFEN SUSPENSION/DROPS; 100MG/2.5ML 1/30/1998 ORAL XTTRIUM DYNA-HEX CHLORHEXIDINE SOLUTION; TOPICAL 0.75% 9/11/1997 GLUCONATE XTTRIUM EXIDINE CHLORHEXIDINE SOLUTION; TOPICAL 4% 12/24/1984 GLUCONATE XTTRIUM EXIDINE CHLORHEXIDINE AEROSOL, METERED; 4% 12/24/1984 GLUCONATE TOPICAL XTTRIUM EXIDINE CHLORHEXIDINE SOLUTION; TOPICAL 2% 12/17/1985 GLUCONATE Notes: This listing contains over-the-counter human drugs currently approved by FDA for sale in the United States. This listing does not include over-the-counter products approved for marketing by FDA through a process other than submission of a New Drug Application or Biologic License Application. Also excluded are dietary supplements, which do not require FDA approval to be sold in the United States.

Source: FDA.gov

Ingredients & Dosages Transferred From Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975

Ingredient Adult Dosage Product Category Date Of OTC Approval Product Examples brompheniramine maleate 4 mg/4-6 hours (oral) antihistamine September 9, 1976 Dimetapp chlorpheniramine maleate 4 mg/4-6 hours (oral) antihistamine September 9, 1976 Chlor-Trimeton, Coridicin HBP, Triaminic Cold & Allergy oxmetazoline 0.05% aqueous solution nasal decongestant September 9, 1976 Afrin, Neo-Synephrine-12 hydrochloride (topical) Hour pseudoephedrine 60 mg/4 or 4-6 hours (oral) nasal decongestant September 9, 1976 Sudafed hydrochloride 240 mg max./24 hours pseudoephedrine sulfate 60 mg/4 or 4-6 hours (oral) nasal decongestant September 9, 1976 Drixoral xylometazoline 0.01% aqueous solution nasal decongestant September 9, 1976 Natru-Vent hydrochloride (topical) doxylamine succinate 25 mg single dose only (oral) sleep aid October 18, 1978 Unisom (NDA) hydrocortisone 0.25 to 0.50% (topical) antipruritic (anti-itch) December 4, 1979+ Cortaid, Lanacort

Source: Consumer Healthcare Products Association 65 Ingredients & Dosages Transferred From Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975

Ingredient Adult Dosage Product Category Date Of OTC Approval Product Examples hydrocortisone acetate 0.25 to 0.50% (topical) antipruritic (anti-itch) December 4, 1979+ Bactine acidulated phosphate 0.02% fluoride in aqueous dental rinse March 28, 1980 fluoride rinse solution sodium fluoride rinse 0.05% aqueous solution dental rinse March 28, 1980 Fluorigard (topical) stannous fluoride gel 0.4% gel (topical) anticaries gel March 28, 1980 GelKam Gel stannous fluoride rinse 0.1% aqueous solution dental rinse March 28, 1980 (topical) ephedrine sulfate 0.1 to 1.25% (topical) anorectal/vasoconstrictor May 27, 1980 Pazo Ointment epinephrine hydrochloride 0.005 to 0.01% (topical) anorectal/vasoconstrictor May 27, 1980 phenylephrine 0.25% (topical) anorectal/vasoconstrictor May 27, 1980 hydrochloride chlorpheniramine maleate 12 mg/12 hours (oral timed- antihistamine July 23, 1981 Triaminic 12 (NDA) release) phenylpropanolamine 75 mg/12 hours (oral timed- nasal decongestant July 23, 1981 hydrochloride (NDA) release) diphenhydramine 25 mg/4 hours (oral) antitussive August 7, 1981 Benylin hydrochloride (NDA) haloprogin 1.0% (topical) antifungal March 23, 1982 miconazole nitrate 2.0% (topical) antifungal March 23, 1982 Micatin diphenhydramine 50 mg single dose only (oral) sleep aid April 23, 1982 Sominex 2 hydrochloride diphenhydramine 76 mg single dose only (oral) sleep aid April 23, 1982 Excedrin PM monocitrate dyclonine hydrochloride 0.05 to 0.1% solution or oral anesthetic May 25, 1982 Sucrets Maximum Strength suspension, 1 to 3 mg as lozenge dexbrompheniramine 6 mg/12 hours (oral timed- antihistamine September 3, 1982 Drixoral maleate (NDA) release) pseudoephedrine sulfate 120 mg/12 hours (oral timed- nasal decongestant September 3, 1982 Afrinol Repetabs (NDA) release) triprolidine hydrochloride 2.5 mg/4-6 hours antihistamine November 26, 1982 Actifed Capsules ibuprofen (NDA) 200 mg/4-6 hours (oral) internal analgesic/ May 18, 1984 Advil, Nuprin antipyretic dexbrompheniramine 2 mg/4-6 hours (oral) antihistamine January 15, 1985 maleate diphenhydramine 25-50 mg/4-6 hours (oral) antihistamine January 15, 1985 Benadryl hydrochloride pseudoephedrine 120 mg/12 hours (oral timed- nasal decongestant June 17, 1985 hydrochloride (NDA) release) triprolidine hydrochloride 5 mg/12 hours antihistamine June 17, 1985 Actifed 12-hour Capsules (NDA) oxymetazoline 0.025% solution/drops ocular vasoconstrictor May 30, 1986 Ocuclear hydrochloride (NDA) (topical) pyrantel pamoate 11 mg/kg of body weight anthelmintic August 1, 1986 Pin-X maximum dose 1 g (oral) povidone iodine sponge 10% (new dosage form) antimicrobial January 7, 1987 E-Z Scrub 241 (NDA) diphenhydramine 25-50 mg/4-6 hours (oral) antiemetic April 30, 1987 hydrochloride dexbrompheniramine 3 mg/6-8 hours (oral) antihistamine May 22, 1987 Drixoral Plus maleate (NDA) chlophedianol 25 mg/6-8 hours (oral) antitussive August 12, 1987 hydrochloride doxylamine succinate 7.5 mg - 12.5 mg./4-6 hours antihistamine August 24, 1987 Nyquil (oral) loperamide (NDA) 4 mg, then 2 mg, 8 mg/day antidiarrheal March 3, 1988 Imodium A-D (Johnson & (oral) Johnson)

Source: Consumer Healthcare Products Association 66 Ingredients & Dosages Transferred From Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975

Ingredient Adult Dosage Product Category Date Of OTC Approval Product Examples hydrogenated soybean oil 12.4 g powder in 2-3 oz. cholecystokinetic February 28, 1989 Liposperse (Merck) and lecithin water 20 minutes before gall bladder x-rays ibuprofen, 200 mg ibuprofen, 30 mg analgesic/decongestant September 19, 1989 Advil Cold and Sinus (Wyeth) pseudoephedrine HCl pseudoephedrine HCl (NDA)* clotrimazole (NDA) 1% lotion and cream/2 times antifungal October 23, 1989 Lotrimin AF (Schering) daily permethrin (NDA) 1% cream rinse pediculicide (head lice) May 5, 1990 Nix (Warner-Lambert) clotrimazole (NDA) 1% cream & 100 mg inserts anticandidal November 30, 1990 Gyne-Lotrimin (Schering), Mycelex-7 (Miles) miconazole nitrate 2.0% cream and 100 mg anticandidal March 13, 1991 Monistat 7 (Ortho) inserts hydrocortisone+ Above 0.50% to 1.0% antipruritic (anti-itch) August 30, 1991 hydrocortisone acetate+ Above 0.50% to 1.0% antipruritic (anti-itch) August 30, 1991 clemastine fumarate (NDA) 1.34 mg/12 hours antihistamine August 21, 1992 Tavist-1 (Novartis) clemastine fumarate 1.34 mg/12 hours antihistamine/ August 21, 1992 Tavist-D (Novartis) (in combination with decongestant phenylpropanolamine HCl (NDA) dexchlorpheniramine 2 mg/4-6 hours (oral) antihistamine December 9, 1992 (last monograph switch) maleate naproxen sodium (NDA) 220 mg/4-6 hours (oral) internal analgesic/ January 11, 1994 Aleve (Bayer) antipyretic pheniramine maleate with 0.3%; 0.025% in solution ophthalmic antihistamine/ June 8, 1994 Naphcon A (Alcon), Opcon naphazoline HCl (NDA) decongestant A (Bausch & Lomb) Ocuhist (Akorn) antazoline phosphate with 0.5%; 0.05% in solution ophthalmic antihistamine/ July 11, 1994 Vasocon A (Ciba) naphazoline HCl (NDA) decongestant famotidine (NDA) 10 mg, up to 20 mg/day acid reducer April 28, 1995 Pepcid AC (J&J·Merck) ibuprofen suspension 7.5 mg/kg up to 4 times a internal analgesic/antipyretic June 16, 1995 Children’s Motrin (McNeil 100mg/5ml for pediatric day Consumer) use (NDA) cimetidine (NDA) 200 mg up to twice per day acid reducer June 19, 1995 Tagamet HB (GlaxoSmithKline) ketoprofen (NDA) 12.5 mg every 4 to 6 hours internal analgesic October 6, 1995 Orudis KT (Wyeth), Actron (Bayer) ranitidine (NDA) 75 mg up to twice per day acid reducer December 19, 1995 Zantac 75 (McNeil) butoconazole nitrate (NDA) 2.0% cream and applicators anticandidal December 26, 1995 Femstat 3 (Procter & (3 days) Gamble) minoxidil (NDA) 2.0% topical solution hair grower February 9, 1996 Rogaine (McNeil) nicotine polacrilex (NDA) 2 mg and 4 mg gum smoking cessation February 9, 1996 Nicorette (GlaxoSmithKline) nizatidine (NDA) 75 mg up to twice daily acid reducer May 9, 1996 AXID AR (Wyeth) miconazole nitrate (NDA) 2.0% cream and 200-mg anticandidal April 16, 1996 Monistat 3 (Ortho) inserts nicotine transdermal 15 mg. patch smoking cessation July 3, 1996 Nicotrol (McNeil Consumer) system (NDA) clotrimazole (NDA)* 1% cream & 200 mg inserts anticandidal July 29, 1996 Gyne-Lotrimin 3 (Schering- Plough) nicotine transdermal 21, 14, & 7 mg patch smoking cessation August 2, 1996 Nicoderm CQ system (NDA) (GlaxoSmithKline Beecham) Habitrol (Novartis) (Nov. 12, 1999) bentoquatam (NDA)* 5% lotion poison ivy protection August 26, 1996 Ivy Block (EnviroDerm) cromolyn sodium (NDA) 4% nasal solution allergy prevention & January 6, 1997 Nasalcrom (McNeil treatment Consumer) tioconazole (NDA) 6.5% vaginal ointment anticandidal February 11, 1997 Vagistat-1 (Bristol-Myers Squibb), Monistat 1 (McNeil) loperamide/simethicone 2 mg loperamide, 125 mg antidiarrheal/antigas June 26, 1997 Imodium Advanced (McNeil (NDA)* simethicone Consumer)

Source: Consumer Healthcare Products Association 67 Ingredients & Dosages Transferred From Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975

Ingredient Adult Dosage Product Category Date Of OTC Approval Product Examples triclosan (dentifrice) 0.30% triclosan/0.243% antigingivitis July 11, 1997 Total (Colgate-Palmolive) (NDA)* fluoride ketoconazole (NDA) 1% shampoo dandruff shampoo October 10, 1997 Nizoral (Johnson & Johnson Consumer Products) minoxidil (NDA)* 5.0% topical solution hair grower November 17, 1997 Rogaine Extra Strength for Men (Johnson & Johnson) aspirin /caffeine / 250 mg/65 mg/250 mg migraine January 14, 1998 Excedrin Migraine (Novartis) acetaminophen (NDA)** miconazole nitrate (NDA)* 4.0% cream anticandidal March 30, 1998 Monistat 3 (Advanced Care Products) terbinafine hydrochloride 1.0% cream antifungal March 9, 1999 Lamisil AT (Novartis) (NDA) cimetidine suspension Suspension acid reducer July 9, 1999 Tagamet HB 200 (NDA)* (GlaxoSmithKline) naproxen Na, 220 mg naproxen Na, 120 analgesic/decongestant November 29, 1999 Aleve Cold & Sinus (Bayer pseudoephedrine HCl mg pseudoephedrine HCl Consumer Care) (NDA)* ibuprofen (NDA)** 200 mg migraine February 25, 2000 Motrin Migraine Pain (McNeil Consumer Healthcare) ibuprofen (NDA)** 200 mg migraine March 16, 2000 Advil Migraine Liqui-Gels (Wyeth) docosanol (NDA)* 10% cream cold sore/fever blister July 25, 2000 Abreva Cream (Avanir Pharmaceuticals) famotidine, calcium 10 mg famotidine, 800 mg heartburn, acid indigestion October 17, 2000 Pepcid Complete (J&J/ carbonate, magnesium calcium carbonate, 165 mg Merck) hydroxide (NDA)* magnesium hydroxide butenafine hydrochloride 1.0% cream athlete’s foot, jock itch, December 7, 2001 Lotrimin Ultra (Schering- (NDA) ringworm Plough) ibuprofen, 100 mg ibuprofen, 15 mg analgesic/decongestant April 18, 2002 Children’s Advil Cold (Wyeth) pseudoephedrine HCl, pseudo-ephedrine HCl/5 ml; suspension for pediatric 5 or 10 ml up to 4 times a day use (NDA)* guaifenesin extended- 600 or 1200 mg once or twice expectorant July 12, 2002 Mucinex (Adams Respiratory release tablet (NDA) a day Therapeutics) nicotine polacrilex troche/ 2 mg and 4 mg smoking cessation October 31, 2002 Commit (GlaxoSmithKline) lozenge (NDA)* loratadine (NDA) 10 mg/day antihistamine November 27, 2002 Claritin Tablets, Claritin RediTabs, Claritin Syrup (Schering-Plough) loratadine, 10 mg loratadine, 240 mg antihistamine/ decongestant November 27, 2002 Claritin-D 12 Hour Extended pseudoephededrine sulfate pseudoephedrine sulfate Release Tablets, Claritin-D (NDA) Daily 24 Hour Extended Release Tablets (Schering-Plough) omeprazole magnesium 20 mg/day acid reducer to treat June 20, 2003 Prilosec OTC (Procter & (NDA) frequent heartburn Gamble) loratadine (NDA)** 10 mg/day hives relief November 15, 2003 Claritin hives relief (Schering- Plough) diphenhydramine citrate 400 mg ibuprofen and 78 analgesic sleep-aid December 21, 2005 Advil PM (Wyeth) & ibuprofen (NDA)*; mg diphenhydramine citrate diphenhydramine HCl or 50 mg diphenhydramine & ibuprofen potassium HCl at bedtime (NDA)* ecamsule (combined 2% ecamsule; 2% sunscreen July 21, 2006 Anthelios SX (L’Oreal) with avobenzone and avobenzone; 10% octocrylene (NDA)* octocrylene levonorgestrel (NDA) Two 0.75-mg tablets, with the contraceptive August 24, 2006 Plan B (Duramed) second one taken 12 hours after the first polyethylene glycol 3350 17 g (scoopful) of powder laxative October 6, 2006 MiraLAX (Schering-Plough) (NDA) per day in 8 oz. of water ketotifen (NDA) 0.025% ophthalmic solution antihistamine eye drops October 19, 2006 Zaditor (Novartis) orlistat (NDA) 60 mg; 180 mg daily max. weight loss aid February 7, 2007 alli (GlaxoSmithKline)

Source: Consumer Healthcare Products Association 68 Ingredients & Dosages Transferred From Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975

Ingredient Adult Dosage Product Category Date Of OTC Approval Product Examples cetirizine HCl & 5 mg cetirizine and 120 mg antihistamine/decongestant November 9, 2007 Zyrtec-D (McNeil) pseudoephedrine HCl pseudoephedrine (NDA) cetirizine HCl (NDA) 1 mg/ml (children’s syrup), 5 antihistamine, hives relief November 16, 2007 Zyrtec (McNeil) mg and 10 mg (tablets and chewable tablets) lansoprazole (NDA) 15 mg/day acid reducer to treat May 18, 2009 Prevacid 24 HR (Novartis) frequent heartburn levonorgestrel (NDA) 1.5 mg contraceptive July 10, 2009 Plan B One Step (Duramed) omeprazole and sodium 20 mg omeprazole and 1100 acid reducer to treat December 1, 2009 Zegerid OTC (Schering- bicarbonate (NDA) mg sodium bicarbonate frequent heartburn Plough) ibuprofen and 200 mg ibuprofen and 10 mg analgesic/decongestant May 27, 2010 Advil Congestion Relief phenylephrine HCl (NDA) phenylephrine HCl (Pfizer) fexofenadine hydrochloride 30 mg; 60 mg; 180 mg 30 antihistamine January 24, 2011 Allegra (Chattem) (NDA) mg/5 mL fexofenadine hydrochloride 60 mg; 120 mg antihistamine/decongestant January 24, 2011 Allegra D 12-Hour (Chattem) and pseudoephedrine HCl (NDA) fexofenadine hydrochloride 180 mg; 240 mg antihistamine/decongestant January 24, 2011 Allegra D 24-Hour (Chattem) and pseudoephedrine HCl (NDA) Notes: List is updated through Feb. 7, 2011 + FDA approval for OTC marketing is on an interim basis pending adoption of a Final Monograph * New OTC NDA – Not previously Rx **New OTC indication, product previously OTC

Source: Consumer Healthcare Products Association

OTC Product U.S. Patent Data: By Company

3M HEALTH CARE INC. Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date ALCOHOL; AVAGARD SOLUTION; 5897031 June 21, 2016 CHLORHEXIDINE TOPICAL GLUCONATE - 61%;1% ALCOHOL; AVAGARD SOLUTION; 6090395 June 22, 2015 CHLORHEXIDINE TOPICAL GLUCONATE - 61%;1% ALCOHOL; AVAGARD SOLUTION; 6534069 June 22, 2015 CHLORHEXIDINE TOPICAL GLUCONATE - 61%;1% ALCOHOL; AVAGARD SOLUTION; 6623744 June 23, 2015 U-1008 CHLORHEXIDINE TOPICAL GLUCONATE - 61%;1% ALCOHOL; AVAGARD SOLUTION; 7081246 August 3, 2016 CHLORHEXIDINE TOPICAL GLUCONATE - 61%;1% ALCOHOL; AVAGARD SOLUTION; 7566460 June 22, 2015 U-1008 CHLORHEXIDINE TOPICAL GLUCONATE - 61%;1% IODINE POVACRYLEX; DURAPREP SPONGE; NC September 29, ISOPROPYL ALCOHOL - EQ TOPICAL 2009 0.7% IODINE;74% (26ML) IODINE POVACRYLEX; DURAPREP SPONGE; NC September 29, ISOPROPYL ALCOHOL - EQ TOPICAL 2009 0.7% IODINE;74% (6ML)

Source: eKnowledgeBase 69 ASTRAZENECA LP

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date OMEPRAZOLE MAGNESIUM PRILOSEC OTC TABLET, 5690960 November 25, - EQ 20MG BASE DELAYED 2014 RELEASE; ORAL OMEPRAZOLE MAGNESIUM PRILOSEC OTC TABLET, 5753265 June 7, 2015 - EQ 20MG BASE DELAYED RELEASE; ORAL OMEPRAZOLE MAGNESIUM PRILOSEC OTC TABLET, 5817338 October 6, 2015 - EQ 20MG BASE DELAYED RELEASE; ORAL OMEPRAZOLE MAGNESIUM PRILOSEC OTC TABLET, 5900424 May 4, 2016 - EQ 20MG BASE DELAYED RELEASE; ORAL OMEPRAZOLE MAGNESIUM PRILOSEC OTC TABLET, 6403616 November 15, - EQ 20MG BASE DELAYED 2019 RELEASE; ORAL OMEPRAZOLE MAGNESIUM PRILOSEC OTC TABLET, 6428810 November 3, - EQ 20MG BASE DELAYED 2019 RELEASE; ORAL

BANNER PHARMACAPS INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date IBUPROFEN - 200MG MIDOL LIQUID CAPSULE; 6251426 June 25, 2018 GELS ORAL

BOEHRINGER INGELHEIM PHARMACEUTICALS INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date RANITIDINE ZANTAC 150 TABLET; ORAL 5098715 December 20, HYDROCHLORIDE - EQ 2010 150MG BASE

CAREFUSION 213 LLC

Source: eKnowledgeBase 70 CAREFUSION 213 LLC

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date CHLORHEXIDINE CHLORAPREP SPONGE; 5772346 April 22, 2017 GLUCONATE; ISOPROPYL ONE-STEP TOPICAL ALCOHOL - 2%;70% FREPP (1.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; D386849 November 25, GLUCONATE; ISOPROPYL ONE-STEP TOPICAL 2011 ALCOHOL - 2%;70% FREPP (1.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; D396911 August 11, 2012 GLUCONATE; ISOPROPYL ONE-STEP TOPICAL ALCOHOL - 2%;70% FREPP (1.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 5690958 September 30, GLUCONATE; ISOPROPYL ONE-STEP TOPICAL 2016 ALCOHOL - 2%;70% (10.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 5690958 September 30, GLUCONATE; ISOPROPYL WITH TINT TOPICAL 2016 ALCOHOL - 2%;70% (10.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6536975 November 10, GLUCONATE; ISOPROPYL ONE-STEP TOPICAL 2020 ALCOHOL - 2%;70% (10.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6536975 November 10, GLUCONATE; ISOPROPYL WITH TINT TOPICAL 2020 ALCOHOL - 2%;70% (10.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6729786 March 14, 2023 GLUCONATE; ISOPROPYL WITH TINT TOPICAL ALCOHOL - 2%;70% (10.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6991393 January 31, 2024 GLUCONATE; ISOPROPYL WITH TINT TOPICAL ALCOHOL - 2%;70% (10.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 7241065 March 14, 2023 GLUCONATE; ISOPROPYL WITH TINT TOPICAL ALCOHOL - 2%;70% (10.5ML) CHLORHEXIDINE CHLORAPREP SPONGE; 5690958 September 30, GLUCONATE; ISOPROPYL ONE-STEP TOPICAL 2016 ALCOHOL - 2%;70% (26ML) CHLORHEXIDINE CHLORAPREP SPONGE; 5690958 September 30, GLUCONATE; ISOPROPYL WITH TINT TOPICAL 2016 ALCOHOL - 2%;70% (26ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6729786 March 14, 2023 GLUCONATE; ISOPROPYL WITH TINT TOPICAL ALCOHOL - 2%;70% (26ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6991393 March 14, 2023 GLUCONATE; ISOPROPYL WITH TINT TOPICAL ALCOHOL - 2%;70% (26ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6991394 January 31, 2024 GLUCONATE; ISOPROPYL ONE-STEP TOPICAL ALCOHOL - 2%;70% (26ML) CHLORHEXIDINE CHLORAPREP SPONGE; 6991394 January 31, 2024 GLUCONATE; ISOPROPYL WITH TINT TOPICAL ALCOHOL - 2%;70% (26ML) CHLORHEXIDINE CHLORAPREP SPONGE; 7182536 December 30, GLUCONATE; ISOPROPYL ONE-STEP TOPICAL 2023 ALCOHOL - 2%;70% (26ML)

Source: eKnowledgeBase 71 CAREFUSION 213 LLC

DR. REDDY’S LABORATORIES LTD.

DURAMED PHARMACEUTICALS INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date LEVONORGESTREL - PLAN B TABLET; ORAL NP August 24, 2009 0.75MG LEVONORGESTREL - 1.5MG PLAN B ONE- TABLET; ORAL NP July 10, 2012 STEP

GLAXOSMITHKLINE CONSUMER HEALTHCARE

Source: eKnowledgeBase 72 GLAXOSMITHKLINE CONSUMER HEALTHCARE

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date NICOTINE POLACRILEX - NICORETTE TROCHE/ 5110605 August 21, 2010 EQ 2MG BASE LOZENGE; ORAL NICOTINE POLACRILEX - COMMIT TROCHE/ 5110605 August 21, 2010 EQ 4MG BASE LOZENGE; ORAL NICOTINE POLACRILEX - NICORETTE TROCHE/ 5110605 August 21, 2010 EQ 4MG BASE LOZENGE; ORAL ORLISTAT - 60MG ALLI CAPSULE; 6004996 January 6, 2018 NP February 7, 2010 ORAL

GLAXOSMITHKLINE INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date DOCOSANOL - 10% ABREVA CREAM; 4874794 April 28, 2014 U-815 TOPICAL DOCOSANOL - 10% ABREVA CREAM; 5534554 December 13, U-815 TOPICAL 2013

HISAMITSU PHARMACEUTICAL CO. INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date MENTHOL; METHYL SALONPAS PATCH; NDF February 20, 2011 SALICYLATE - 3%;10% TOPICAL MENTHOL; METHYL SALONPAS PATCH; NC February 20, 2011 SALICYLATE - 3%;10% TOPICAL

JOHNSON & JOHNSON GROUP OF CONSUMER COMPANIES

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date MINOXIDIL - 5% MEN’S AEROSOL, 6946120 April 20, 2019 U-702 ROGAINE FOAM; TOPICAL

JOHNSON & JOHNSON HEALTHCARE PRODUCTS

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date MICONAZOLE NITRATE - MONISTAT 1 CREAM, 5514698 March 21, 2014 2%,1.2GM COMBINATION SUPPOSITORY; PACK TOPICAL, VAGINAL MICONAZOLE NITRATE - MONISTAT 1 CREAM, 6153635 November 28, 2%,1.2GM COMBINATION SUPPOSITORY; 2020 PACK TOPICAL, VAGINAL

Source: eKnowledgeBase 73 LES ENTREPRISES SOLUMED INC.

L’OREAL USA PRODUCTS INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date AVOBENZONE; ECAMSULE; ANTHELIOS SX CREAM; 5587150 December 24, U-752 NC July 21, 2009 OCTOCRYLENE - TOPICAL 2013 2%;2%;10% AVOBENZONE; ECAMSULE; CAPITAL CREAM; NP October 2, 2009 OCTOCRYLENE - SOLEIL 15 TOPICAL 2%;3%;10% AVOBENZONE; ECAMSULE; CAPITAL CREAM; NC July 21, 2009 OCTOCRYLENE - SOLEIL 15 TOPICAL 2%;3%;10% AVOBENZONE; ECAMSULE; ANTHELIOS 20 CREAM; NC October 5, 2009 OCTOCRYLENE; TITANIUM TOPICAL DIOXIDE - 2%;2%;10%;2% AVOBENZONE; ECAMSULE; ANTHELIOS 40 CREAM; NC October 5, 2009 OCTOCRYLENE; TITANIUM TOPICAL DIOXIDE - 2%;3%;10%;5% AVOBENZONE; ECAMSULE; ANTHELIOS 40 CREAM; NP March 31, 2011 OCTOCRYLENE; TITANIUM TOPICAL DIOXIDE - 2%;3%;10%;5% AVOBENZONE; ECAMSULE; ANTHELIOS 40 CREAM; NP October 29, 2012 OCTOCRYLENE; TITANIUM TOPICAL DIOXIDE - 2%;3%;10%;5%

MCNEIL CONSUMER PRODUCTS CO., A DIV. OF MCNEILAB INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date CETIRIZINE ZYRTEC-D 12 TABLET, 6469009 July 13, 2019 U-295 HYDROCHLORIDE; HOUR EXTENDED PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE - 5MG;120MG CETIRIZINE ZYRTEC-D 12 TABLET, 6489329 April 8, 2016 HYDROCHLORIDE; HOUR EXTENDED PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE - 5MG;120MG CETIRIZINE ZYRTEC-D 12 TABLET, 7014867 June 10, 2022 HYDROCHLORIDE; HOUR EXTENDED PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE - 5MG;120MG CETIRIZINE ZYRTEC-D 12 TABLET, 7226614 June 10, 2022 U-295 HYDROCHLORIDE; HOUR EXTENDED PSEUDOEPHEDRINE RELEASE; ORAL HYDROCHLORIDE - 5MG;120MG IBUPROFEN - 100MG/5ML CHILDREN’S SUSPENSION; 5374659 December 20, MOTRIN ORAL 2011 IBUPROFEN - 100MG/5ML CHILDREN’S SUSPENSION; 5374659*PED June 20, 2012 MOTRIN ORAL

Source: eKnowledgeBase 74 MCNEIL CONSUMER PRODUCTS CO., A DIV. OF MCNEILAB INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date LOPERAMIDE IMODIUM A-D TABLET, 5489436 February 6, 2013 HYDROCHLORIDE - 2MG EZ CHEWS CHEWABLE; ORAL LOPERAMIDE IMODIUM A-D TABLET, 6814978 August 26, 2021 HYDROCHLORIDE - 2MG EZ CHEWS CHEWABLE; ORAL LOPERAMIDE IMODIUM TABLET, 5248505 July 28, 2010 HYDROCHLORIDE; MULTI- CHEWABLE; SIMETHICONE - SYMPTOM ORAL 2MG;125MG RELIEF LOPERAMIDE IMODIUM TABLET, 5489436 February 6, 2013 HYDROCHLORIDE; MULTI- CHEWABLE; SIMETHICONE - SYMPTOM ORAL 2MG;125MG RELIEF LOPERAMIDE IMODIUM TABLET, 5612054 September 28, HYDROCHLORIDE; MULTI- CHEWABLE; 2010 SIMETHICONE - SYMPTOM ORAL 2MG;125MG RELIEF LOPERAMIDE IMODIUM TABLET, 5679376 October 21, 2014 HYDROCHLORIDE; MULTI- CHEWABLE; SIMETHICONE - SYMPTOM ORAL 2MG;125MG RELIEF LOPERAMIDE IMODIUM TABLET, 5716641 May 21, 2012 U-226 HYDROCHLORIDE; MULTI- CHEWABLE; SIMETHICONE - SYMPTOM ORAL 2MG;125MG RELIEF

MCNEIL CONSUMER HEALTHCARE

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date IBUPROFEN - 100MG JUNIOR TABLET, 5215755*PED December 1, STRENGTH CHEWABLE; 2010 MOTRIN ORAL IBUPROFEN - 40MG/ML CHILDREN’S SUSPENSION/ 5374659 December 20, MOTRIN DROPS; ORAL 2011 IBUPROFEN - 40MG/ML CHILDREN’S SUSPENSION/ 5374659*PED June 20, 2012 MOTRIN DROPS; ORAL IBUPROFEN - 50MG CHILDREN’S TABLET, 5215755*PED December 1, MOTRIN CHEWABLE; 2010 ORAL IBUPROFEN; CHILDREN’S SUSPENSION; 6211246 June 10, 2019 PSEUDOEPHEDRINE MOTRIN COLD ORAL HYDROCHLORIDE - 100MG/5ML;15MG/5ML KETOCONAZOLE - 1% NIZORAL A-D SHAMPOO; 5456851 April 7, 2014 TOPICAL LOPERAMIDE IMODIUM TABLET; ORAL 6103260 July 17, 2017 HYDROCHLORIDE; MULTI- SIMETHICONE - SYMPTOM 2MG;125MG RELIEF

Source: eKnowledgeBase 75 MERCK SHARP & DOHME CORP.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date CALCIUM CARBONATE; PEPCID TABLET, 5075114*PED November 23, FAMOTIDINE; MAGNESIUM COMPLETE CHEWABLE; 2010 HYDROXIDE - ORAL 800MG;10MG;165MG CALCIUM CARBONATE; PEPCID TABLET, 5229137 May 16, 2012 U-349 FAMOTIDINE; MAGNESIUM COMPLETE CHEWABLE; HYDROXIDE - ORAL 800MG;10MG;165MG CALCIUM CARBONATE; PEPCID TABLET, 5229137*PED November 16, FAMOTIDINE; MAGNESIUM COMPLETE CHEWABLE; 2012 HYDROXIDE - ORAL 800MG;10MG;165MG CALCIUM CARBONATE; PEPCID TABLET, 5989588 September 30, U-349 FAMOTIDINE; MAGNESIUM COMPLETE CHEWABLE; 2015 HYDROXIDE - ORAL 800MG;10MG;165MG CALCIUM CARBONATE; PEPCID TABLET, 5989588*PED March 30, 2016 U-349 FAMOTIDINE; MAGNESIUM COMPLETE CHEWABLE; HYDROXIDE - ORAL 800MG;10MG;165MG CALCIUM CARBONATE; PEPCID TABLET, 6814978 August 26, 2021 FAMOTIDINE; MAGNESIUM COMPLETE CHEWABLE; HYDROXIDE - ORAL 800MG;10MG;165MG CALCIUM CARBONATE; PEPCID TABLET, 6814978*PED February 26, 2022 FAMOTIDINE; MAGNESIUM COMPLETE CHEWABLE; HYDROXIDE - ORAL 800MG;10MG;165MG FAMOTIDINE - 10MG PEPCID AC TABLET; ORAL 5854267 December 29, U-267 2015 FAMOTIDINE - 10MG PEPCID AC TABLET; ORAL 5854267 December 29, U-368 (GELTAB) 2015 FAMOTIDINE - 10MG PEPCID AC TABLET; ORAL 5854267*PED June 29, 2016 U-267 FAMOTIDINE - 10MG PEPCID AC TABLET; ORAL 5854267*PED June 29, 2016 U-368 (GELTAB) FAMOTIDINE - 20MG PEPCID AC TABLET, 5075114*PED November 23, CHEWABLE; 2010 ORAL FAMOTIDINE - 20MG PEPCID AC TABLET, 6814978 August 26, 2021 CHEWABLE; ORAL FAMOTIDINE - 20MG PEPCID AC TABLET, 6814978*PED February 26, 2022 CHEWABLE; ORAL

NOVARTIS CONSUMER HEALTH INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date ACETAMINOPHEN; EXCEDRIN TABLET; ORAL 5972916 July 14, 2017 U-296 ASPIRIN; CAFFEINE - (MIGRAINE) 250MG;250MG;65MG LANSOPRAZOLE - 15MG PREVACID CAPSULE, NP May 18, 2012 24 HR DELAYED REL PELLETS; ORAL TERBINAFINE - 1% LAMISIL AT GEL; TOPICAL 5681849 October 28, 2014 TERBINAFINE - 1% LAMISIL AT GEL; TOPICAL 5681849*PED April 28, 2015 TERBINAFINE - 1% LAMISIL AT GEL; TOPICAL 5856355 May 18, 2012 U-504 TERBINAFINE - 1% LAMISIL AT GEL; TOPICAL 5856355 May 18, 2012 U-540 TERBINAFINE - 1% LAMISIL AT GEL; TOPICAL 5856355*PED November 18, 2012

Source: eKnowledgeBase 76 NOVARTIS CONSUMER HEALTH INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date TERBINAFINE LAMISIL AT SOLUTION; 5681849 October 28, 2014 HYDROCHLORIDE - 1% TOPICAL TERBINAFINE LAMISIL AT SPRAY; 5681849 October 28, 2014 HYDROCHLORIDE - 1% TOPICAL TERBINAFINE LAMISIL AT SOLUTION; 5681849*PED April 28, 2015 HYDROCHLORIDE - 1% TOPICAL TERBINAFINE LAMISIL AT SPRAY; 5681849*PED April 28, 2015 HYDROCHLORIDE - 1% TOPICAL

PERRIGO R&D CO.

PFIZER INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date CETIRIZINE CHILDREN’S TABLET, 6455533 July 2, 2018 U-295 HYDROCHLORIDE - 10MG ZYRTEC CHEWABLE; ALLERGY ORAL CETIRIZINE CHILDREN’S TABLET, 6455533 July 2, 2018 U-295 HYDROCHLORIDE - 10MG ZYRTEC HIVES CHEWABLE; RELIEF ORAL CETIRIZINE CHILDREN’S TABLET, 6455533 July 2, 2018 U-295 HYDROCHLORIDE - 5MG ZYRTEC CHEWABLE; ALLERGY ORAL CETIRIZINE CHILDREN’S TABLET, 6455533 July 2, 2018 U-295 HYDROCHLORIDE - 5MG ZYRTEC HIVES CHEWABLE; RELIEF ORAL

RECKITT BENCKISER INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date DEXTROMETHORPHAN MUCINEX DM TABLET, 6955821 April 28, 2020 U-685 HYDROBROMIDE; EXTENDED GUAIFENESIN - RELEASE; ORAL 60MG;1.2GM DEXTROMETHORPHAN MUCINEX DM TABLET, 7838032 April 28, 2020 HYDROBROMIDE; EXTENDED GUAIFENESIN - RELEASE; ORAL 60MG;1.2GM DEXTROMETHORPHAN DELSYM SUSPENSION, 5980882 April 16, 2017 POLISTIREX - EQ 30MG EXTENDED HBR/5ML RELEASE; ORAL GUAIFENESIN - 1.2GM MUCINEX TABLET, 6372252 April 28, 2020 U-489 EXTENDED RELEASE; ORAL GUAIFENESIN - 1.2GM MUCINEX TABLET, 6955821 April 28, 2020 U-489 EXTENDED RELEASE; ORAL GUAIFENESIN - 1.2GM MUCINEX TABLET, 7838032 April 28, 2020 EXTENDED RELEASE; ORAL GUAIFENESIN - 600MG MUCINEX TABLET, 6372252 April 28, 2020 U-489 EXTENDED RELEASE; ORAL GUAIFENESIN - 600MG MUCINEX TABLET, 6955821 April 28, 2020 U-489 EXTENDED RELEASE; ORAL GUAIFENESIN - 600MG MUCINEX TABLET, 7838032 April 28, 2020 EXTENDED RELEASE; ORAL GUAIFENESIN; MUCINEX D TABLET, 6372252 April 28, 2020 PSEUDOEPHEDRINE EXTENDED HYDROCHLORIDE - RELEASE; ORAL 1.2GM;120MG GUAIFENESIN; MUCINEX D TABLET, 6955821 April 28, 2020 U-686 PSEUDOEPHEDRINE EXTENDED HYDROCHLORIDE - RELEASE; ORAL 1.2GM;120MG GUAIFENESIN; MUCINEX D TABLET, 7838032 April 28, 2020 PSEUDOEPHEDRINE EXTENDED HYDROCHLORIDE - RELEASE; ORAL 1.2GM;120MG GUAIFENESIN; MUCINEX D TABLET, 6372252 April 28, 2020 PSEUDOEPHEDRINE EXTENDED HYDROCHLORIDE - RELEASE; ORAL 600MG;60MG GUAIFENESIN; MUCINEX D TABLET, 6955821 April 28, 2020 U-686 PSEUDOEPHEDRINE EXTENDED HYDROCHLORIDE - RELEASE; ORAL 600MG;60MG GUAIFENESIN; MUCINEX D TABLET, 7838032 April 28, 2020 PSEUDOEPHEDRINE EXTENDED HYDROCHLORIDE - RELEASE; ORAL 600MG;60MG

SAGE PRODUCTS INC.

Source: eKnowledgeBase 78 SAGE PRODUCTS INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date CHLORHEXIDINE CHLOR- CLOTH; 7427574 April 25, 2026 GLUCONATE - 2% HEXIDINE TOPICAL GLUCONATE CHLORHEXIDINE CHLOR- CLOTH; 7595021 May 12, 2023 U-1022 GLUCONATE - 2% HEXIDINE TOPICAL GLUCONATE

SANOFI-AVENTIS U.S. LLC

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date NICOTINE - 14MG/24HR NICODERM FILM, 5508038 April 16, 2013 CQ EXTENDED RELEASE; TRANSDERMAL NICOTINE - 21MG/24HR NICODERM FILM, 5508038 April 16, 2013 CQ EXTENDED RELEASE; TRANSDERMAL NICOTINE - 7MG/24HR NICODERM FILM, 5508038 April 16, 2013 CQ EXTENDED RELEASE; TRANSDERMAL

SCHERING-PLOUGH HEALTHCARE PRODUCTS INC.

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date LORATADINE - 1MG/ML CLARITIN SYRUP; ORAL 6132758 June 1, 2018 LORATADINE; CLARITIN-D 24 TABLET, 5314697 October 23, 2012 PSEUDOEPHEDRINE HOUR EXTENDED SULFATE - 10MG;240MG RELEASE; ORAL OMEPRAZOLE; SODIUM ZEGERID OTC CAPSULE; 6489346 July 15, 2016 U-1025 BICARBONATE - ORAL 20MG;1.1GM OMEPRAZOLE; SODIUM ZEGERID OTC CAPSULE; 6645988 July 15, 2016 BICARBONATE - ORAL 20MG;1.1GM OMEPRAZOLE; SODIUM ZEGERID OTC CAPSULE; 6699885 July 15, 2016 BICARBONATE - ORAL 20MG;1.1GM OMEPRAZOLE; SODIUM ZEGERID OTC CAPSULE; 7399772 July 15, 2016 U-1025 BICARBONATE - ORAL 20MG;1.1GM POLYETHYLENE GLYCOL MIRALAX FOR SOLUTION; NP Oct 6, 2009 3350 - 17GM/SCOOPFUL ORAL

WYETH CONSUMER HEALTHCARE

Marketing Patent Patent Expire Patent Use Marketing Exclusivity Ingredient - Strength Trade Name Dosage Number Date Code Exclusivity Code Expiration Date IBUPROFEN; ADVIL TABLET; ORAL 5087454 July 30, 2010 PHENYLEPHRINE CONGESTION HYDROCHLORIDE - RELIEF 200MG;10MG

Source: eKnowledgeBase 79 OTC Class I Devices – General Controls – 510(k)

Product Name Product Code Regulation Number Medical Specialty Cleanser, Denture, Over The Counter EFT 872.3520 Dental Container, Specimen, Urine, Drugs Of Abuse, Over The Counter MPQ 864.3260 Pathology Lipoprotein, High Density, Hdl, Over The Counter NAQ 862.1175 Clinical Chemistry Test, Cholesterol, Total, Over The Counter NFX 862.1175 Clinical Chemistry Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA 862.1300 Clinical Chemistry Test, Lactic Acid, Over The Counter NGD 862.1450 Clinical Chemistry Test, Luteinizing Hormone (Lh), Over The Counter NGE 862.1485 Clinical Chemistry Test, Nitrite, Urinary, Non-Quantitative, Over The Counter NGJ 862.1510 Clinical Chemistry Test, Triglycerides, Over The Counter NGO 862.1705 Clinical Chemistry Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter NKJ 872.3540 Dental

OTC Class II Devices – General Controls and Special Controls – 510(k)

Product Name Product Code Regulation Number Medical Specialty Over The Counter Denture Repair Kit EBO 872.3570 Dental Reliner, Denture, Over The Counter EBP 872.3560 Dental Pad, Denture, Over The Counter EHR 872.3540 Dental Cushion, Denture, Over The Counter EHS 872.3540 Dental Kit, Test, Pregnancy, Hcg, Over The Counter LCX 862.1155 Clinical Chemistry System, Test, Blood Glucose, Over The Counter NBW 862.1345 Clinical Chemistry Test, Amphetamine, Over The Counter NFT 862.3100 Clinical Toxicology Test, Benzodiazepine, Over The Counter NFV 862.3170 Clinical Toxicology Test, Cannabinoid, Over The Counter NFW 862.3870 Clinical Toxicology Test, Cocaine And Cocaine Metabolites, Over The NFY 862.3250 Clinical Toxicology Counter Test, Creatinine, Over The Counter NFZ 862.1225 Clinical Chemistry Test, Glycosylated Hemoglobin, Over The Counter NGB 864.7470 Hematology Test, Methamphetamine, Over The Counter NGG 862.3610 Clinical Toxicology Test, Morphine, Over The Counter NGI 862.3640 Clinical Toxicology Test, Occult Blood, Over The Counter NGK 864.6550 Hematology Test, Opiates, Over The Counter NGL 862.3650 Clinical Toxicology Light Based Over The Counter Wrinkle Reduction OHS 878.4810 General and Plastic Surgery Light Based Over-The-Counter Hair Removal OHT 878.4810 General and Plastic Surgery

OTC Unclassified Devices – 510(k)

Product Name Product Code Regulation Number Medical Specialty Kit, Test, Multiple, Drugs Of Abuse, Over The Counter MVO

Source: MDRWeb.com 80