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April Through June 2014

April Through June 2014

April through June 2014

Undeclared Drug Ingredient Found in MV5 Days: Updated Warnings—Current Drugs The FDA is advising consumers not to purchase or use MV5 Days, a product promoted and sold for sexual en- hancement. FDA laboratory analysis confirmed that MV5 Public Notification Regarding Male Sexual En- Days contains , the active ingredient in the FDA hancement Products: The FDA is advising consumers approved prescription drug Viagra, used to treat ED. This not to purchase or use GoldReallas, Full Throttle On De- undeclared ingredient may interact with nitrates found in mand, 3 Hard Knights, Dick’s Hard Up, Eyeful, Liu Bian Li, some prescription drugs such as nitroglycerin and may products promoted and sold for sexual enhancement on lower blood pressure to dangerous levels. Men with diabe- various websites and in some retail stores. FDA laboratory tes, high blood pressure, high , or heart disease analysis confirmed that these products contained the fol- often take nitrates. lowing undeclared drug ingredients: MV5 Days is a product promoted and sold for sexual en- • GoldReallas: sildenafil and thiosildenafil hancement on various websites and in some retail stores. • Full Throttle On Demand: propoxyphenyl sildenafil FDA is recommending that consumers do not purchase or • 3 Hard Knights: sildenafil and thiosildenafil use MV5 Days. (5/16/14) • Dick’s Hard Up: • Eyeful: hydroxythiohomosildenafil Lunesta—Next Day Impairments: The FDA has noti- • Liu Bian Li: sildenafil fied health professionals and their medical care organiza- These undeclared ingredients may interact with nitrates tions of a new warning that the insomnia drug Lunesta found in some prescription drugs such as nitroglycerin and (eszopiclone) can cause next-day impairment of driving may lower blood pressure to dangerous levels. and other activities that require alertness. FDA recom- Sildenafil is the active ingredient in the FDA approved pre- mends a decreased starting dose of Lunesta to 1 mg at bed- scription drug Viagra, used to treat erectile dysfunction time. Women and men are equally susceptible to impair- (ED). The other undeclared ingredients are structurally ment from Lunesta, so the recommended starting dose of 1 similar to sildenafil. mg is the same for both. FDA approved changes to the Consumers should stop using these products immediately Lunesta prescribing information and the patient Medica- and throw them away. Consumers who have experienced tion Guide to include these new recommendations. The any negative side effects should consult a health care pro- drug labels for generic eszopiclone products will also be fessional as soon as possible. (6/3/14) updated to include these changes. A study of Lunesta found that the previously recommended Asset Bold: Undeclared Drug Ingredient: The FDA dose of 3 mg can cause impairment to driving skills, is advising consumers not to purchase or use Asset Bold, a memory, and coordination that can last more than 11 hours product promoted and sold for weight loss. FDA laboratory after receiving an evening dose. Despite these driving and analysis confirmed that Asset Bold contains sibutramine. other problems, patients were often unaware they were Sibutramine is a controlled substance that was removed impaired. The new lower recommended starting dose of 1 from the market in October 2010 for safety reasons. The mg at bedtime will result in less drug in the blood the next product poses a threat to consumers because sibutramine day. is known to substantially increase blood pressure and/or Health care professionals should follow the new dosing pulse rate in some patients and may present a significant recommendations when starting patients on Lunesta. Pa- risk for patients with a history of coronary artery disease, tients should continue taking their prescribed dose of congestive heart failure, arrhythmias, or stroke. These Lunesta and contact their health care professionals to ask products may also interact, in life-threatening ways, with about the most appropriate dose for them. FDA is continu- other a consumer may be taking. ing to evaluate the risk of impaired mental alertness with Asset Bold is a product promoted and sold for weight loss the entire class of sleep aid drugs, including over-the- on various websites and in some retail stores. counter drugs available without a prescription, and will The FDA is recommending that consumers do not purchase update the public as new information becomes available. or use Asset Bold. (5/16/14) (5/15/14) www.AmericanHealthCare.com

For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 1 Pradaxa Study by FDA: Increased Risk of GI Bleed- life-threatening ways, with other medications a consumer ing: The FDA recently completed a new study in Medicare may be taking. patients comparing Pradaxa to warfarin, for risk of ischem- Natural Body Solution is promoted and sold for weight loss ic or clot-related stroke, bleeding in the brain, major gas- and sold on various websites and in some retail stores. trointestinal (GI) bleeding, myocardial infarction (MI), and FDA is advising consumers not to purchase or use Natural death. The new study found that among new users of Body Solution. (5/6/14) blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and Slim Trim U: Undeclared Drug Ingredient Found: death, than warfarin. The study also found an increased The FDA laboratory analysis confirmed that Slim Trim U risk of major gastrointestinal bleeding with use of Pradaxa contains sibutramine. Sibutramine is a controlled sub- as compared to warfarin. The MI risk was similar for the stance that was removed from the market in October 2010 two drugs. for safety reasons. The product poses a threat to consumers Importantly, the new study is based on a much larger and because sibutramine is known to substantially increase older patient population than those used in FDA’s earlier blood pressure and/or pulse rate in some patients and may review of post-market data, and employed a more sophisti- present a significant risk for patients with a history of cor- cated analytical method to capture and analyze the events onary artery disease, congestive heart failure, arrhythmias, of concern. As a result of these latest findings, the FDA still or stroke. These products may also interact, in life- considers Pradaxa to have a favorable benefit to risk profile threatening ways, with other medications a consumer may and have made no changes to the current label or recom- be taking. mendations for use. Slim Trim U is promoted and sold for weight loss and sold Pradaxa and warfarin are used to reduce the risk of stroke on various websites and in some retail stores. and blood clots in patients with a common type of abnor- FDA is advising consumers not to purchase or use Slim mal heart rhythm called non-valvular atrial fibrillation Trim U. (5/6/14) (AF). Patients should not stop taking Pradaxa (or warfarin) with- GenStrip Blood Glucose Test Strip—Safety Risk: out first talking with their health care professionals. Stop- The FDA is advising people with diabetes and health care ping the use of blood-thinning medications such as professionals to stop using GenStrip Blood Glucose Test Pradaxa and warfarin can increase the risk of stroke and Strips because the strips may report incorrect blood glu- lead to permanent disability and death. Health care profes- cose levels. sionals who prescribe Pradaxa should continue to follow During a recent inspection of Shasta Technologies LLC, the the dosing recommendations in the drug label. (5/13/14) FDA found extensive violations of federal regulations in- tended to assure the quality of products in the manufactur- Asset Bee Pollen—Undeclared Drug Ingredient: ing of GenStrip Test Strips. FDA found that Shasta Tech- The FDA is advising consumers not to purchase or use As- nologies did not have in place many of the requirements of set Bee Pollen, a product promoted and sold for weight a quality system. Without assurance of an adequate quality loss. FDA laboratory analysis confirmed that Asset Bee Pol- system, the FDA believes that the strips could report incor- len contains sibutramine. Sibutramine is a controlled sub- rect blood glucose levels. stance that was removed from the market in October 2010 GenStrip Blood Glucose Test Strips, sold by Shasta Tech- for safety reasons. The product poses a threat to consumers nologies LLC, are "third-party" blood glucose monitoring because sibutramine is known to substantially increase test strips. Shasta’s GenStrips are advertised for use with blood pressure and/or pulse rate in some patients and may the LifeScan OneTouch family of glucose meters (e.g. Ultra, present a significant risk for patients with a history of cor- Ultra 2 and Ultra Mini). onary artery disease, congestive heart failure, arrhythmias, Discontinue use of GenStrip Blood Glucose Test Strips. or stroke. These products may also interact, in life- FDA recommends the use of alternative glucose test strips threatening ways, with other medications a consumer may that are designed for use with the LifeScan OneTouch fami- be taking. ly of glucose meters. (4/29/14) Asset Bee Pollen is a product promoted and sold for weight loss on various websites. FDA Finds Undeclared Drug Ingredients in The FDA is recommending patients not purchase or use S.W.A.G: The FDA is advising consumers not to purchase Asset Bee Pollen. (5/12/14) or use S.W.A.G, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that Natural Body Solution—Undeclared Drug Ingredi- S.W.A.G contains sildenafil, the active ingredient in the ent: The FDA laboratory analysis confirmed that Natural FDA approved prescription drug Viagra, used to treat ED. Body Solution contains sibutramine. Sibutramine is a con- This undeclared ingredient may interact with nitrates trolled substance that was removed from the market in Oc- found in some prescription drugs such as nitroglycerin and tober 2010 for safety reasons. The product poses a threat to may lower blood pressure to dangerous levels. Men with consumers because sibutramine is known to substantially diabetes, high blood pressure, high cholesterol, or heart increase blood pressure and/or pulse rate in some patients disease often take nitrates. and may present a significant risk for patients with a histo- S.W.A.G. is promoted and sold on various websites and in ry of coronary artery disease, congestive heart failure, ar- some retail stores. rhythmias, or stroke. These products may also interact, in For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 2 Consumers should stop using this product immediately and pediatric patients with PAH. FDA issued a Drug Safety throw it away. Consumers who have experienced any nega- Communication at that time. There may be situations in tive side effects should consult a health care professional as which the benefit-risk profile of Revatio may be acceptable soon as possible. (4/18/14) in individual children, for example, when other treatment options are limited and Revatio can be used with close Zi Xiu Tang Bee Pollen Capsules Warning form monitoring. FDA: The FDA is warning consumers to immediately stop The purpose of the August 2012 recommendation was to using Zi Xiu Tang Bee Pollen, marketed as a product for raise awareness of clinical trial results showing a higher weight loss and body reshaping. The product contains at risk of mortality in pediatric patients taking a high dose of least one potentially harmful active pharmaceutical ingre- Revatio when compared to pediatric patients taking a low dient that is not listed on the product’s label. dose. This recommendation was not intended to suggest The FDA has tested multiple Zi Xiu Tang Bee Pollen prod- that Revatio should never be used in children; however, ucts from various distributors in the United States. All some health care professionals have interpreted this infor- products that have been tested, including those that claim mation as a contraindication, and have refused to prescribe to be “genuine” and “anti-counterfeit,” have been found to or administer the drug. contain one or both of the following undeclared drug in- The evidence behind FDAs initial recommendation has not gredients: changed; this communication is clarifying the strength of • Sibutramine – a controlled substance that was re- the warning communicated in the Revatio drug label. moved from the market in October 2010 for safety rea- (3/31/14) sons. The product poses a threat to consumers because sibutramine is known to substantially increase blood Recalls/Suspensions pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Adverse Event Reporting Program (contact coronary artery disease, congestive heart failure, ar- information located at the end of the bulletin). rhythmias or stroke. • Phenolphthalein – a chemical that is not an active in- gredient in any approved drug in the United States. African Black Ant, Black Ant, and Mojo Risen Studies have indicated that it presents a cancer-causing Products: Eugene Oregon, Inc. is voluntarily conducting risk. this recall because FDA analysis of these products distrib- The FDA has received dozens of adverse event reports, in- uted to a third party revealed that the distributed products cluding many serious cardiac issues, associated with the contained undeclared amounts of the active pharmaceuti- use of Zi Xiu Tang Bee Pollen. Reports have included heart cal ingredients sildenafil and tadalafil—FDA-approved palpitations, tachycardia (increased heart rate), suicidal pharmaceutical ingredients used to treat ED. Conclusive thoughts, chest pain, diarrhea, anxiety, insomnia, in- testing has not been done to confirm that the recalled creased blood pressure and seizure. Consumers who have products do, in fact, contain sildenafil and/or tadalafil and experienced any negative side effects while taking this this recall is being executed as a precautionary measure. product should consult a health care professional. Sildenafil and tadalafil can pose a threat to consumers be- Zi Xiu Tang Bee Pollen is manufactured by Guangzhou Zi cause they can interact with nitrates found in some pre- Xiu Tang Biotechnology Co., Ltd. in Guangdong Province, scription drugs (such as nitroglycerin), resulting in de- China. It is offered for sale on the Internet, and it can be creased blood pressure. Nitrates are found in prescription found in various retail stores, spas and fitness centers. In drugs used to treat diabetes, high blood pressure, high cho- addition, licensed health care professionals have promoted lesterol, and heart disease. Sildenafil and tadalafil can also the product. cause side effects such as headaches and flushing. The FDA is investigating the distribution of Zi Xiu Tang Eugene Oregon, Inc. has discontinued the distribution of Bee Pollen products in the United States and may issue these products and is notifying its distributors by mail of warning letters or take enforcement action, such as sei- this voluntary recall. zures, injunctions and/or criminal charges. (4/8/14) Consumers that possess these products should stop using them immediately and can return the products to Eugene Revatio Pediatric Use Warning: The FDA is clarifying Oregon, Inc., 922 S. Woodbourne Rd. #304, Levittown, PA its previous recommendation related to prescribing Revatio 19057-1001. Consumers should contact their physician or (sildenafil) for children with pulmonary arterial hyperten- healthcare provider if they have experienced any problems sion (PAH). Revatio is FDA-approved only to treat PAH in that may be related to using these products. Consumers adults, not in children; however, health care professionals with questions regarding this recall can contact Eugene must consider whether the benefits of treatment with the Oregon, Inc. by telephone at 1-800-538-3411 from Monday drug are likely to outweigh its potential risks for each pa- through Friday between 9:00 a.m. and 5:00 p.m. EST. tient. (5/6/14) FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic Nova Products, Inc.—Dietary Supplements: Nova use, is not recommended in children.” This recommenda- Products, Inc. issued a voluntary recall of the following tion was based on an observation of increasing mortality products: African Black Ant (Lot# 2006-000926), Black with increasing Revatio doses in a long-term clinical trial in Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 3 ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# New Life Nutritional Dietary Supplements: New 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 Life Nutritional Center is recalling all lots of “Super Fat (Lot# 13071012) at the retail level. The FDA laboratory Burner capsules, Maxi Gold capsules and Esmeralda analysis on these products has determined that they con- softgels” to the user level after FDA analysis revealed the tain undeclared amounts of sildenafil and tadalafil, active products contain undeclared active pharmaceutical ingre- ingredients of FDA-approved drugs used to treat ED. These dients: sibutramine, phenolphthalein, or a combination of undeclared active ingredients pose a threat to consumers both sibutramine and phenolphthalein. because they can interact with nitrates found in some pre- Sibutramine is an appetite suppressant that was withdrawn scription drugs (such as nitroglycerin), resulting in de- from the U.S. market in October 2010 (due to increased creased blood pressure. Prescription drugs containing ni- risk of seizures, heart attacks, arrhythmias, and strokes). trates are frequently prescribed for individuals with diabe- Phenolphthalein is an ingredient previously used in over- tes, high blood pressure, high cholesterol, or heart disease. the-counter laxatives, but because of concerns of carcino- Additionally, these products may cause side effects such as genicity, it is not currently approved for marketing in the headaches and flushing. United States. These undeclared ingredients make these These products are marketed as dietary supplements for products unapproved new drugs for which safety and effi- sexual enhancement and packaged in blister packs, enve- cacy have not been established. lopes, bottles, and/or boxes distributed to consumers na- These products are used as weight loss aids and are pack- tionwide at retail stores. Lot numbers are identified on the aged in 30 capsule bottles. New Life Nutritional Center dis- back or side of each product. tributed these products to customers residing in NY, NJ, Consumers that possess these products should stop using LA, TX, VA, and MA via retail stores and internet sales them immediately and return the products to Nova Prod- through their website at www.newlifenutritional.com. ucts, Inc., 5 Mount Pleasant Road, Aston, Pennsylvania. New Life Nutritional Center is notifying its customers by Consumers with questions regarding this recall can contact letter. Customers are advised to immediately discontinue Nova Products, Inc. by telephone at 610-459-7709 between use of these products and should return the products im- 9:00 a.m. and 5:00 p.m. EST. Consumers should contact mediately to New Life Nutritional Center 714 West 181st their physician or healthcare provider if they have experi- Street NY, NY 10033 for a refund. (3/26/14) enced any problems that may be related to taking or using these products. (3/31/14) Approved Drugs

Bella Vi Brand Products by Pure Edge Nutrition: Please access www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm for in-depth drug approval information. Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Sivextro Approved by FDA to Treat Skin Infections: Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi The FDA today approved Sivextro (tedizolid phosphate), a Amp’d Up, to the consumer level. The FDA laboratory new antibacterial drug, to treat adults with skin infections. analyses found the products to contain undeclared Sivextro is approved to treat patients with acute bacterial sibutramine or a combination of both sibutramine and skin and skin structure infections (ABSSSI) caused by cer- phenolphthalein. Sibutramine was removed from the US tain susceptible bacteria, including Staphylococcus aureus market in October 2010 for safety reasons and (including methicillin-resistant strains (MRSA) and methi- phenophthalein is used as a laxative and not approved for cillin-susceptible strains), various Streptococcus species, marketing in the US. Therefore, these products are and Enterococcus faecalis. Sivextro is available for intrave- unapproved new drugs. nous and oral use. Products containing sibutramine and phenophthalein pose Sivextro is the second new antibacterial drug approved by a threat to consumers because sibutramine can increase the FDA in the past month to treat ABSSSI. On May 23, the blood pressure and/or pulse rate in some patients and may agency approved Dalvance (dalbavancin), also to treat pa- present a risk for those with a history of coronary artery tients with ABSSSI caused by Staphylococcus aureus and disease, congestive heart failure, arrhythmias, or stroke. various Streptococcus species. These products may also interact in life threatening ways Sivextro’s safety and efficacy were evaluated in two clinical with other medications a consumer may be taking. trials with 1,315 adults with ABSSSI. Participants were ran- All affected products are marketed as dietary supplements domly assigned to receive Sivextro or linezolid, another for weight loss. antibacterial drug approved to treat ABSSSI. Results Pure Edge Nutrition, LLC is notifying its distributors and showed Sivextro was as effective as linezolid for the treat- customers by email and is arranging for return of all ment of ABSSSI. The most common side effects identified recalled products. Consumers and distributors that have in the clinical trials were nausea, headache, diarrhea, vom- product which is being recalled should stop using and iting and dizziness. The safety and efficacy of Sivextro have return products to Pure Edge Nutrition, LLC. Consumers not been evaluated in patients with decreased levels of with questions regarding this recall can contact Pure Edge white blood cells (neutropenia), so alternative therapies Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00 should be considered. a.m. – 2:00 p.m. EST or email info@pureedgenutrition. Sivextro is marketed by Cubist Pharmaceuticals, based in com. (3/26/14) Lexington, Massachusetts. (6/23/14)

For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 4 Zontivity: The FDA approved Zontivity (vorapaxar) tab- Common side effects experienced by Cyramza-treated par- lets to reduce the risk of heart attack, stroke, cardiovascular ticipants during clinical testing include diarrhea and high death, and need for procedures to restore the blood flow to blood pressure. the heart in patients with a previous heart attack or block- The FDA reviewed Cyramza under its priority review pro- ages in the arteries to the legs. gram, which provides an expedited review for drugs that Zontivity is the first in a new class of drug, called a prote- have the potential, at the time the application was submit- ase-activated receptor-1 (PAR-1) antagonist. It is an anti- ted, to be a significant improvement in safety or effective- platelet agent, designed to decrease the tendency of plate- ness in the treatment of a serious condition. Cyramza was lets to clump together to form a blood clot. By decreasing also granted orphan product designation because it is in- the formation of blood clots, Zontivity decreases the risk of tended to treat a rare disease or condition. heart attack and stroke. Cyramza is marketed by Indianapolis-based Eli Lilly. Like other drugs that inhibit blood clotting, Zontivity in- (4/22/14) creases the risk of bleeding, including life-threatening and fatal bleeding. Bleeding is the most commonly reported Ragwitek for Short Ragweed Pollen Allergies: The adverse reaction in people taking Zontivity. The drug’s pre- FDA approved Ragwitek, the first allergen extract adminis- scribing information (label) includes a Boxed Warning to tered under the tongue (sublingually) to treat short rag- alert health care professionals about this risk. weed pollen induced allergic rhinitis (hay fever), with or Zontivity must not be used in people who have had a without conjunctivitis (eye inflammation), in adults 18 stroke, transient ischemic attack, or bleeding in the head, years through 65 years of age. because the risk of bleeding in the head is too great. Ragwitek contains an extract from short ragweed (Ambro- Patients should report to their health care professional any sia artemisiifolia) pollen. It is a tablet that is taken once unanticipated, prolonged or excessive bleeding, or blood in daily by placing it sublingually, where it rapidly dissolves. their stool or urine. Zontivity will be dispensed with an Treatment with Ragwitek is started 12 weeks before the FDA-approved patient Guide that provides in- start of ragweed pollen season and continued throughout structions for its use and important safety information. the season. The first dose is taken in a health care profes- Zontivity is made by Merck Sharp & Dohme Corp., a sub- sional’s office where the patient is to be observed for at sidiary of Merck & Co., Inc. of Whitehouse Station, N.J. least 30 minutes for potential adverse reactions. After the (5/8/14) first dose, patients can take Ragwitek at home. Individuals with allergic rhinitis with or without conjuncti- Epanova: Epanova, generic name omega-3-carboxylic vitis may experience a runny nose, repetitive sneezing, na- acids, has been approved by the FDA. Epanova is indicated sal itching, nasal congestion, and itchy and watery eyes. as an adjunct to diet to treat severe hypertriglyceridemia in Short ragweed pollen is one of the most common seasonal adult patients. Severe hypertriglyceridemia is defined as allergens and is prevalent during the late summer and early triglyceride levels of greater than or equal to 500mg/dL. fall months in most of the United States. Short ragweed Epanova is manufactured by AstraZeneca and is available pollen induced allergies are generally managed by avoiding in capsule form. (5/7/14) the allergen, medications to relieve symptoms, or with al- lergy shots. Incruse Ellipta: The FDA has approved GlaxoSmith- The Prescribing Information includes a boxed warning to Kline’s Incruse Ellipta (umeclidinium) once-daily inhala- inform that severe allergic reactions, some of which can be tion powder for the treatment of long-term maintenance of life-threatening, can occur. Ragwitek also has a Medication airflow obstruction in patients diagnosed with chronic ob- Guide for distribution to the patient. structive pulmonary disease (COPD); also including chron- Ragwitek is manufactured for Merck, Sharp & Dohme ic bronchitis and/or emphysema. GlaxoSmithKline antici- Corp., (a subsidiary of Merck and Co., Inc., Whitehouse pates a fourth quarter 2014 launch of Incruse Ellipta. Station, N.J.) by Catalent Pharma Solutions Limited, Unit- (5/1/14) ed Kingdom. (4/18/14)

Cyramza for Stomach Cancer: The FDA approved Tanzeum Injection: The FDA today approved Tanzeum Cyramza (ramucirumab) to treat patients with advanced () subcutaneous injection to improve glycemic stomach cancer or gastroesophageal junction adenocarci- control, along with diet and exercise, in adults with type 2 noma, a form of cancer located in the region where the diabetes. esophagus joins the stomach. Type 2 diabetes affects approximately 24 million people Stomach cancer forms in the tissues lining the stomach and and accounts for more than 90 percent of diabetes cases mostly affects older adults. According to the National Can- diagnosed in the United States. Over time, high blood sugar cer Institute, an estimated 22,220 Americans will be diag- levels can increase the risk for serious complications, in- nosed with stomach cancer and 10,990 will die from the cluding heart disease, blindness, and nerve and kidney disease, this year. damage. Cyramza is an angiogenesis inhibitor that blocks the blood Tanzeum is a glucagon-like -1 (GLP-1) receptor ag- supply to tumors. It is intended for patients whose cancer onist, a hormone that helps normalize blood sugar levels. cannot be surgically removed (unresectable) or has spread Tanzeum should not be used to treat people with type 1 (metastatic) after being treated with a fluoropyrimidine- or diabetes; those who have increased ketones in their blood platinum-containing therapy. For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 5 or urine (diabetic ketoacidosis); or as first-line therapy for FDA Approves Generic Vesicare: The FDA approved patients who can’t be managed with diet and exercise. the generic equivalent of Vesicare, solifenacin succinate, Tanzeum has a Boxed Warning to warn that tumors of the used for the treatment of overactive bladder with symp- thyroid gland (thyroid C-cell tumors) have been observed toms of urinary frequency, urgency, or urge incontinence. in rodent studies with some GLP-1 receptor agonists, but Solifenacin succinate is manufactured by Teva Pharmaceu- that it is unknown whether Tanzeum causes thyroid C-cell ticals and is available as a 5mg and 10mg tablet. (4/20/14) tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not Generic Lunesta Approved: Mylan Inc. today an- be used in patients with a personal or family history of nounced that it has launched Eszopiclone Tablets 1 mg, 2 MTC or in patients with Multiple Endocrine Neoplasia mg and 3 mg, the generic version of Sunovion Pharmaceu- syndrome type 2 (a disease where patients have tumors in ticals Inc.'s Lunesta. Mylan received final approval from more than one gland in their body and that predisposes the FDA for its Abbreviated New Drug Application (ANDA) them to MTC). for this product, which is indicated for the treatment of The FDA approved Tanzeum with a Risk Evaluation and insomnia. (4/16/14) Mitigation Strategy (REMS), which consists of a communi- cation plan to inform health care providers about the seri- Approval of Generic Lovaza by Teva: Teva Pharma- ous risks associated with Tanzeum. (4/16/14) ceutical Industries Ltd. announced the approval of the ge- neric equivalent to Lovaza (omega-3-acid ethyl esters cap- Otezla: The FDA approved Otezla (apremilast) to treat sules, USP), in the United States. Omega-3-acid ethyl esters adults with active psoriatic arthritis (PsA). is available as 1 gram oral capsules containing at least PsA is a form of arthritis that affects some people with pso- 900mg of the ethyl esters of omega-3 fatty acids. Omega- riasis. Most people develop psoriasis first and are later di- 3-acid ethyl esters are used as adjunct to diet therapy in the agnosed with PsA. Joint pain, stiffness, and swelling are treatment of hypertriglyceridemia (triglycerides ≥ 500 the main signs and symptoms of PsA. Currently approved mg/dL). Teva plans to commence shipping immediately. treatments for PsA include corticosteroids, tumor necrosis (4/10/14) factor (TNF) blockers, and an interleukin-12/interleukin- 23 inhibitor. Generic Mepron Suspension Approval: The generic The FDA is requiring a pregnancy exposure registry as a of brand name Mepron, atovaquone, was approved by the post-marketing requirement to assess the risks to pregnant FDA for patients intolerant to trimethoprim- women related to Otezla exposure. sulfamethoxazole (TMP-SMZ) to prevent pneumocystis In clinical trials, the most common side effects observed in carinii pneumonia (PCP). This drug is also approved in patients treated with Otezla were diarrhea, nausea, and patients intolerant to TMP-SMZ for short-term oral headache. treatment of mild to moderate PCP. Atovaquone is Otezla is manufactured for Celgene Corporation, Summit, manufactured by Amneal Pharmaceuticals and is available N.J. (3/21/14) as a 750mg/5mL oral suspension. (3/24/14)

New Generics New Indications

Generic Celebrex Approved: The FDA approved the Reyataz—Expanded Indication and New Dosage first generic versions of Celebrex () capsules, a Form: The FDA has approved an expanded indication for treatment for rheumatoid arthritis, osteoarthritis, short- Reyataz (atazanavir) to include pediatric patients at least 3 term (acute) pain, and other conditions. months of age who weigh at least 10 kg for the treatment of Teva Pharmaceutical Industries received approval to mar- HIV-1 infection in combination with other antiretroviral ket celecoxib capsules in 50 milligram (mg), 100 mg, 200 agents. Previously, Reyataz was only indicated for the mg, and 400 mg strengths, and has 180-day exclusivity on treatment of adults and pediatrics at least 6 years of age. the 100 mg, 200 mg, and 400 mg strength products. Mylan Additionally, the FDA has approved a new oral powder Pharmaceuticals, Inc. received approval to market 50 mg dosage form for use in treatment-naive or treatment- celecoxib capsules. experienced pediatric patients who are at least 3 months of Celecoxib is a non-steroidal anti-inflammatory drug age and weigh between 10 kg and less than 25 kg. (6/4/14) (NSAID). All NSAIDs have a Boxed Warning in their pre- scribing information (label) to alert health care profession- Expanded Indication for Arzerra: The FDA has ap- als and patients about the risk of heart attack or stroke that proved an expanded indication for GlaxoSmithKline’s can lead to death. This chance increases for people with Arzerra (ofatumumab). This expanded indication now in- heart disease or risk factors for it, such as high blood pres- cludes the treatment of previously untreated chronic lym- sure, or taking NSAIDs for long periods of time. The Boxed phocytic leukemia (CLL) in combination with Warning also highlights the risk of serious, potential life- in those who are unable to take . Arzerra is also threatening GI bleeding that has been associated with use indicated for the treatment of those with CLL refractory to of NSAIDs. (5/30/14) fludarabine and alemtuzumab. (4/22/14)

For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 6 Expanded Indication for Pradaxa: The FDA has ap- proved an expanded indication for Boehringer Ingelheim’s Miscellaneous Pradaxa (dabigatran etexilate) capsules to include the treatment of deep venous thrombosis (DVT) and pulmo- nary embolism (PE) in patients who have been treated with Nexium 24HR Approved for OTC: The FDA approved an injectable anticoagulant for 5 to 10 days, and to reduce over-the-counter Nexium® 24HR (esomeprazole 20mg). the risk of recurrent DVT and PE in patients who have been In 2012, Pfizer acquired exclusive global rights from Astra- previously treated. Pradaxa is also indicated for the preven- Zeneca to market non-prescription Nexium®. Pfizer con- tion of stroke and systemic embolism in patients with tinue to work closely with AstraZeneca and retail partners nonvalvular atrial fibrillation. Pradaxa labeling now also to make Nexium® 24HR available to consumers in the includes an updated Boxed Warning regarding the risk of U.S., with other markets in Europe expected to follow this spinal/epidural hematoma in patients receiving neuraxial year. (3/28/14) anesthesia or undergoing spinal puncture, in addition to the existing warning that premature discontinuation in- U.S. Food and Drug Administration’s creases the risk of thrombotic events. Pradaxa is dispensed with a patient Medication Guide. (4/8/14) MedWatch Adverse Event Reporting Program

Please contact MedWatch to voluntarily report a serious Kalbitor Expanded Indication: The FDA has approved adverse event, product quality problem, product use error, an expanded indication for Dyax’s Kalbitor (ecallantide) to or therapeutic failure that you suspect is associated with the include the treatment of acute attacks of hereditary angi- use of an FDA-regulated drug, biologic, medical device, die- oedema in patients 12 years of age and older. Kalbitor was tary supplement or cosmetic. You can also report suspected previously approved for treatment in patients16 years of counterfeit medical products to the FDA through MedWatch. age and older. The prescribing information for Kalbitor ______includes a Boxed Warning regarding the risk of anaphylaxis To report a serious problem: and it is dispensed with a patient Medication Guide. (4/7/14) 1-800-332-1088 (phone) 1-800-FDA-0178 (fax) Indication for Baraclude Expanded by the FDA: ______Baraclude, known generically as entecavir, has been approved by the FDA for use in children who have the MedWatch online: chronic hepatitis B virus with active viral replication and evidence of either persistent elevations in serum http://www.fda.gov/MedWatch/report.htm aminotransferases or histologically active disease. Use in ______children is approved for those who are two years or older. By mail (use postage-paid FDA Form 3500): Previously, this medication was only approved for use in adult patients. Baraclude is manufactured by Bristol-Myers MedWatch Squibb. (3/26/14) 5600 Fishers Lane Rockville, MD 20857 FDA Expands Xolair Indication: Xolair (omalizumab) injection is now approved by the FDA to treat patients 12 years and older with chronic idiopathic urticaria who still FUTURE DRUG RELEASES experience symptoms despite H1 antihistamine treatment. LISTED ON NEXT PAGE. This drug is also approved to treat moderate to severe persistent asthma in patients 12 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who still experience symptoms due to inadequate control with inhaled corticosteroids. Xolair’s label does contain a boxed warning stating the risk of anaphylaxis after administration. (3/24/14)

Revised Labeling/ Prescribing Information

Synera for Home Use: The FDA has approved a label change that will allow patients to use Synera ( and tetracaine) topical patch at home. Galan US’s Synera patch is indicated for use in patients 3 years and older on intact skin to provide local analgesia for superficial venous access and superficial dermatological procedures. (6/4/14)

For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 7

NON-SPECIALTY Non-Specialty Generic Drugs Pipeline † indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Brand Brand Route of Generic Name Indication(s) / Use Approval / Name Manufacturer Administration Market Date nedocromil Alocril Allergan Ophthalmic Allergies approved† metformin/ Avandamet GlaxoSmithKline Oral Type 2 diabetes approved† rosiglitazone rosiglitazone Avandia GlaxoSmithKline Oral Type 2 diabetes approved† celecoxib Celebrex Pfizer Oral Osteoarthritis, pain approved† phenoxy- Dibenzyline Roxane Oral Pheochromocytoma approved† benzamine Lamictal ODT Actavis Oral Seizures approved† ODT Diabetic peripheral neuropathy, postherpetic Lyrica Pfizer Oral approved† neuralgia, seizures, fibromyalgia Orapred prednisolone Shionogi Pharma Oral Asthma, atopic dermatitis, allergic rhinitis approved† ODT valganciclovir Valcyte Roche Oral Cytomegalovirus approved† mometasone Nasonex Schering Nasal Allergies JUL 2014 furoate bimatoprost Lumigan Allergan Ophthalmic Glaucoma, ocular hypertension AUG 2014 sevelamer hydro- Renagel Genzyme Oral chronic kidney disease (CKD) SEP 2014 chloride / Exforge Novartis Oral High blood pressure OCT 2014 valsartan amlodipine/ Exforge Novartis Oral High blood pressure OCT 2014 valsartan/HCTZ HCT guanfacine ER Attention deficit hyperactivity Intuniv Actavis Oral DEC 2014 tablets disorder (ADHD) lovastatin/niacin Advicor Abbott Oral Cholesterol 2014 mesalamine Asacol Warner Chilcott Oral Ulcerative colitis, proctitis 2014 valsartan Diovan Novartis Oral High blood pressure 2014 lanthanum Fosrenol Shire Oral Hyperphosphatemia associated with CKD 2014 carbonate ER Invega Janssen Oral Schizophrenia 2014 ethinyl estradiol/ Loestrin Warner Chilcott Oral Birth control pill 2014 norethindrone 24 Fe esomeprazole Nexium AstraZeneca Oral Gastroesophageal reflux disease, ulcers 2014 oxycodone ER Oxycontin Purdue Oral Moderate to severe pain 2014 cyclosporine Restasis Allergan Ophthalmic Chronic dry eye 2014 nelfinavir Viracept ViiV Healthcare Oral Antiretroviral 2014 mesylate estradiol Vivelle-Dot Novartis Transdermal Symptoms of menopause 2014 transdermal patch trandolapril/ Tarka Abbott Oral High blood pressure FEB 2015 colesevelam tablet Welchol Daiichi Sankyo Oral Cholesterol MAR 2015 Abilify Otsuka Oral Psychiatric conditions APR 2015 Chemo-associated nausea & vomiting, aprepitant Emend Merck Oral APR 2015 prevention of post-op nausea & vomiting oxybutynin Oxytrol Watson Transdermal Overactive bladder APR 2015 linezolid Zyvox Pfizer Oral Bacterial infections MAY 2015 / Cipro-HC Bayer Otic Bacterial ear infections JUN 2015 hydrocortisone gemifloxacin Factive Cornerstone Oral Antibiotic JUN 2015 aspirin/ Boehringer Aggrenox Oral Stroke prevention JUL 2015 dipyridamole Ingelheim tablet Namenda Forest Oral Alzheimer’s disease JUL 2015 Androgel testosterone Solvay Topical Hormone replacement AUG 2015 1% Noven Pharma- Daytrana Transdermal ADHD SEP 2015 ceuticals dutasteride Avodart GlaxoSmithKline Oral Benign prostatic hyperplasia 4Q2015

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dutasteride/ Jalyn GlaxoSmithKline Oral Benign prostatic hypertrophy 4Q2015 tamsulosin mesalamine DR Asacol HD Warner Chilcott Oral Ulcerative colitis NOV 2015 Ortho-McNeil- almotriptan Axert Oral Migraine NOV 2015 Janssen frovatriptan suc- Endo Pharma- Frova Oral Migraine NOV 2015 cinate ceuticals norgestimate/ Ortho Tri- Ortho Mcneil Oral Birth control pill DEC 2015 ethinyl estradiol Cyclen Lo Janssen olopatadine Patanol Alcon Ophthalmic Allergic conjunctivitis DEC 2015 metformin hydro- Glumetza Santarus Oral Type 2 diabetes FEB 2016 chloride ER darifenacin Enablex Novartis Oral Overactive bladder MAR 2016 rosuvastatin Crestor AstraZeneca Oral Cholesterol MAY 2016 Nuvigil Teva Oral Sleep disorders JUN 2016 clindamycin/ Ziana Medicis Topical Acne JUL 2016 fluticasone/ Advair Asthma, chronic obstructive GlaxoSmithKline Inhalation AUG 2016 salmeterol Diskus pulmonary disease (COPD) Flovent fluticasone GlaxoSmithKline Inhalation Asthma, COPD AUG 2016 Diskus doxycycline Oracea Lupin, Mylan Oral Rosacea AUG 2016 oseltamivir Tamiflu Gilead Sciences Oral Influenza AUG 2016 olmesartan/ Azor Daiich Sankyo Oral High blood pressure OCT 2016 amlodipine olmesartan Benicar Daiichi Sankyo Oral High blood pressure OCT 2016 Benicar olmesartan/HCTZ Daiichi Sankyo Oral High blood pressure OCT 2016 HCT ER Seroquel AstraZeneca Oral NOV 2016 tablet XR eletriptan Relpax Pfizer Oral Migraines DEC 2016 cinacalcet tablet Sensipar Amgen Oral Hyperparathyroidism, hypercalcemia DEC 2016 ezetimibe Zetia Merck Oral Cholesterol DEC 2016 rasagiline Azilect Teva Oral Parkinson’s disease FEB 2017 ezetimibe/ Vytorin Merck Oral Cholesterol APR 2017 simvastatin Strattera Lilly Oral ADHD MAY 2017 tiagabine Gabitril Cephalon Oral Epilepsy JUN 2017 Actavis, Amneal, Apotex, Dr. Red- sildenafil Viagra dy’s, Hetero, Oral Erectile dysfunction DEC 2017 Macleods, Mylan, Teva, Torrent Levitra Teva Oral Erectile dysfunction OCT 2018 testosterone gel Fortesta Actavis Topical Male hypogonadism NOV 2018 rosiglitazone/ Avandaryl GlaxoSmithKline Oral Type 2 diabetes uncertain rivastigmine Exelon Novartis Oral Alzheimer’s disease, Parkinson’s disease uncertain solution alendronate/ Fosamax Merck Oral Osteoporosis uncertain cholecalciferol Plus D

Non-Specialty Brand Drugs Pipeline TBA = to be announced † indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Route of Ad- FDA Filing / Drug Name Manufacturer Indication(s) / Use ministration Approval / Market Date Impavido (miltefosine) Paladin Oral Treatment of leishmaniasis approved† Incruse Ellipta Glaxo Inhalation Asthma, COPD approved† (umeclidinium) SmithKline Jublia (efinaconazole) Kaken, Valeant Topical Distal lateral subungal onychomycosis approved† Chelsea Ther- Northera (droxidopa) Oral Neurogenic orthostatic hypotension approved† apeutics Acute bacterial skin infections, Sivextro (tedizolid phosphate) Trius Oral approved† skin structure infections 9

Zontivity (vorapaxar sulfate) Merck Oral Myocardial infarction approved† Forest, Schizophrenia, acute treatment of manic or TBA () Gedeon Rich- Oral mixed episodes associated with bipolar I 2Q – 3Q2014 ter disorder Hypoactive sexual desire disorder Girosa (filbanserin) Sprout Oral 3Q2014 in premenopausal women Striverdi Respimat Boehringer Inhalation COPD 3Q2014 (olodaterol) Ingelheim Targiniq ER Purdue Oral Management of chronic pain 3Q2014 (oxycodone/naltrexone) Boehringer TBA (empagliflozin) Ingelheim, Oral Type 2 diabetes 3Q2014 Eli Lilly TBA Helsinn, Eisai Oral -induced nausea & vomiting 3Q – 4Q2014 (palonosetron/netupitant) TBA (tavaborole) Anacor Topical Oncyhomycosis JUL 2014 TBA () Merck Oral Insomnia AUG 2014 Vokanamet Janssen Oral Type 2 diabetes AUG 2014 (canagliflozin/metformin) AstraZeneca, Movantik (naloxegol) Oral Opioid-induced constipation SEP 2014 Nektar Trulicity () Eli Lilly SubQ Type 2 diabetes SEP – OCT 2014 AstraZeneca, Xigduo Bristol Myers Oral Type 2 diabetes 4Q2014 (dapagliflozin/metformin) Squibb Onexton (clindamycin/ Valeant Topical Acne NOV 2014 benzoyl peroxide) TBA (nebivolol/valsartan) Forest Oral Hypertension DEC 2014 Glaxo Eperzan, Syncria (albiglutide) SubQ Type 2 diabetes 2014 SmithKline Hyponatremia associated with heart failure, Lixar (lixivaptan) Cornerstone Oral syndrome of inappropriate 2014 antidiuretic hormone Prevention of cardio- and cerebro-vascular TBA Pozen Oral events, reduce risk of gastric ulcers in pa- 2014 (omeprazole/aspirin DR) tients at risk of aspirin-induced gastric ulcers Otitis externa and media with AL-60371 Alcon Otic 2Q2014 (filing*) a tympanostomy tube TBA (ivabradine) Amgen Oral Chronic heart failure 2Q2014 (filing*) TBA (olodaterol/ Boehringer Inhalation COPD 2Q2014 (filing*) tiotropium bromide) Ingelheim Toctino () Basilea, Stiefel Oral Atopic dermatitis (eczema) 2Q2014 (filing*) TBA (eluxadoline Diarrhea-predominant Furiex Oral 3Q2014 (filing*) dihydrochloride) irritable bowel syndrome TBA (patiromer) Relypsa Oral Hyperkalemia in patients with CKD 3Q2014 (filing*) AstraZeneca, Saxadapa Bristol Myers Oral Type 2 diabetes 4Q2014 (filing*) (saxagliptin/dapagliflozin) Squibb TBA (aclidinium Forest, Inhalation COPD 4Q2014 (filing*) bromide/formoterol) Almirall TBA (delafloxacin) Melinta Oral Uncomplicated gonorrhea 4Q2014 (filing*) Boehringer TBA Ingelheim, Oral Type 2 diabetes 4Q2014 (filing*) (empagliflozin/metformin IR) Eli Lilly Ardea Biosci- TBA (lesinurad) ences, Astra- Oral Hyperuricemia, gout 4Q2014 (filing*) Zeneca Boehringer TBA (linagliptin/ Ingelheim, Oral Type 2 diabetes 4Q2014 (filing*) metformin ER) Eli Lilly TBA (pimavanserin) Acadia, Biovail Oral Parkinson’s disease psychosis 4Q2014 (filing*) TBA (/valsartan Novartis Oral Heart failure 4Q2014 (filing*) trisodium hemipentahydrate) Vivagel (astodrimer) Starpharma Vaginal Bacterial vaginosis 4Q2014 (filing*) Grafix (cellular matrix 4Q2014 – 2015 Osiris Topical Diabetic foot ulcers [wound healing]) (filing*) Deovo (head lice treatment) Hatchtech Topical Head lice 2014 (filing*) FP-01 Cerecor Oral Cough 2014 (filing*) 10

The Medicines Ionsys (fentanyl) Transdermal Acute postoperative pain 2014 (filing*) Company Lixiana (edoxaban tosylate) Daiichi Sankyo Oral Stroke prevention in atrial fibrillation 2014 (filing*) SD-101 Scioderm Topical Epidermolysis bullosa 2014 (filing*) TBA (alfentanil) Orexo Sublingual Pain 2014 (filing*) Helsinn Ther- Treatment of cachexia & TBA (anamorelin) Oral 2014 (filing*) apeutics anorexia in cancer patients TBA (asfotase alfa) Alexion SubQ Hypophosphotasia 2014 (filing*) Otsuka, Schizophrenia, adjunctive therapy for TBA () Oral 2014 (filing*) Lundbeck major depressive disorder TBA (evolocumab) Amgen SubQ Hypercholesterolemia 2014 (filing*) TBA (hydrocodone CR/ Charleston acetaminophen/ Oral Pain 2014 (filing*) Laboratories ) Acute uncomplicated influenza as mono- TBA (nitazoxanide) Romark Oral 2014 (filing*) therapy or in combination with oseltamivir TBA (odanacatib) Merck, Celera Oral Osteoporosis 2014 (filing*) TBA (pradigastat) Novartis Oral Familial chylomicronemia syndrome 2014 (filing*) TBA (rifabutin/amoxicillin/ RedHill Oral Helicobacter pylori infection 2014 (filing*) undisclosed PPI) Prevention of chemotherapy-induced TBA (rolapitant) OPKO, Tesaro Oral 2014 (filing*) nausea & vomiting Accidental overexposure to (5- TBA (uridine triacetate) BTG, Wellstat Oral FU) due to dosing errors or impaired clear- 2014 (filing*) ance of 5-FU from the body TBA (omarigliptin) Merck Oral Type 2 diabetes >2014 (filing*) Dainippon TBA (ranirestat) Sumitomo Oral Diabetic peripheral neuropathy >2014 (filing*) Pharma, Eisai Arimenda Adamas, For- Oral Alzheimer’s dementia JAN 2015 (memantine/) est Prestalia (perindopril argi- Symplmed, nine/amlodipine Oral Hypertension JAN 2015 XOMA besylate) Stroke & systemic embolic events risk reduction in non-valvular a-fib, deep vein Savaysa (edoxaban tosylate) Daiichi Sankyo Oral JAN 2015 thrombosis, & prevention of venous thromboembolism Newron, TBA () Oral Parkinson’s disease MAY 2015 Zambon Lixilan Sanofi SubQ Type 2 diabetes 4Q2015 ( glargine/) Boehringer TBA 1Q – 2Q2015 Ingelheim, Oral Type 2 diabetes (empagliflozin/linagliptin) (filing*) Eli Lilly Derma Scienc- TBA (aclerastide) Topical Diabetic foot ulcers 2Q2015 (filing*) es Boehringer TBA (empagliflozin/ Ingelheim, Oral Type 2 diabetes 2Q2015 (filing*) metformin ER) Eli Lilly TBA (bevenopran) Cubist, Eli Lilly Oral Opioid-induced constipation 2Q2015 (filing*) APR 2015 – TBA (fasiglifam hemihy- Takeda Oral Type 2 diabetes MAR 2016 (fil- drates) ing*) AN-2728 Anacor Topical Psoriasis, atopic dermatitis 2015 (filing*) GW Pharma- Cancer pain, Sativex (nabiximols) ceuticals Oral 2015 (filing*) spasticity in multiple sclerosis (MS) Otsuka TBA (auriclosene) NovaBay Ophthalmic Adenoviral conjunctivitis 2015 (filing*) Stedicor (azimilide) Forest Oral Ventricular arrhythmia 2015 (filing*) TBA (bitopertin) Roche Oral Schizophrenia 2015 (filing*) TBA (deferitazole) Shire Oral Iron overload 2015 (filing*) Pearl Thera- TBA (glycopyrronium bro- peutics, Astra- Inhalation COPD 2015 (filing*) mide/formoterol) Zeneca TBA () Shire Ophthalmic Dry eye 2015 (filing*) TBA (masitinib) AB Science Oral Alzheimer’s disease 2015 (filing*) TBA (mavoglurant) Novartis Oral Fragile X syndrome 2015 (filing*)

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TBA (obeticholic acid) Intercept Oral Primary biliary cirrhosis 2015 (filing*) TBA (ozenoxacin) Ferrer Topical Skin & skin structure infections 2015 (filing*) TBA (rifabutin/ RedHill Oral Crohn’s disease 2015 (filing*) clarithromycin/clofazimine) Sanochemia, TBA ( CR) Oral Neuromuscular spasm & spasticity 2015 (filing*) Katama TBA (zirconium silicate) ZS Pharma Oral Hyperkalemia 2015 (filing*) Sanofi Aventis, Lyxumia (lixisenatide) SubQ Type 2 diabetes 2015 (re-filing*) Zealand Probuphine Titan, SubQ Opioid dependence in adults 2015 (re-filing*) () Braeburn Mitizax (allergy immunother- Merck, Rhinitis, asthma allergy symptoms caused by 2015 – 2016 apy tablet Oral ALK-Abello house dust mites (filing*) [dust mite]) Prana Bio- 2015 – 2016 PBT-2 Oral Huntington’s disease technology (filing*) 2015 – 2016 TBA (langlenatide) Hanmi SubQ Type 2 diabetes (filing*) 2015 – 2016 TBA () Novo Nordisk SubQ Type 2 diabetes (filing*) Atherosclerosis, dyslipidemia, 2015 – 2017 (fil- TBA (anacetrapib) Merck Oral hypercholesterolemia ing*) Ryzodeg (insulin Novo Nordisk SubQ Type 1 & type 2 diabetes 2016 degludec/) Huntexil (pridopidine) Teva Oral Huntington’s disease 2016 (filing*) ISIS-APOCIIIRx, Isis SubQ Dyslipidemia, hypercholesterolemia 2016 (filing*) ISIS-304801 RP-5063 Reviva Oral Schizophrenia 2016 (filing*) TBA (auriclosene) NovaBay Topical Impetigo 2016 (filing*) Stroke prevention in atrial fibrillation TBA (betrixaban) Portola Oral patients, prevention of venous 2016 (filing*) thromboembolic events after surgery Addex Thera- TBA (dipraglurant) Oral Levodopa-induced dyskinesia 2016 (filing*) peutics TBA (elagolix) AbbVie Oral Endometriosis 2016 (filing*) TBA (ertugliflozin) Merck, Pfizer Oral Type 2 diabetes 2016 (filing*) TBA (lasmiditan) CoLucid Oral Treatment of migraine 2016 (filing*) TBA (sotagliflozin) Lexicon Oral Type 2 diabetes 2016 (filing*) TBA (surotomycin) Cubist Oral Clostridium difficile-associated diarrhea 2016 (filing*) TBA (valbenazine) Neurocrine Oral Tardive dyskinesia 2016 (filing*) Warner Zydena (udenafil) Oral BPH & Erectile dysfunction 2016 (filing*) Chilcott TBA (/ 2016 – 2017 (fil- Pharnext SAS Oral Charcot-Marie-Tooth disease type 1A naltrexone/sorbitol) ing*) Ideglira (insulin Novo Nordisk SubQ Type 2 diabetes 1Q2017 (filing*) degludec/) BCT-197 Novartis Oral COPD >2017 (filing*) BGS-649 Novartis Oral Obese hypogonadotropic hypogonadism >2017 (filing*) LFF-571 Novartis Oral Clostridium difficile infection >2017 (filing*) LIK-066 Novartis Oral Type 2 diabetes >2017 (filing*) QAW-039 Novartis Oral Asthma >2017 (filing*) TBA (amilomotide) Novartis, Cytos SubQ Alzheimer’s disease >2017 (filing*) TBA Novartis Inhalation Asthma, COPD >2017 (filing*) (mometasone/indacaterol) Astellas, TBA (roxadustat) Oral Anemia associated with CKD 2018 (filing*) AstraZeneca CM-AT Curemark Oral Autism uncertain Decrease birthing time to vaginal delivery for Misopress (misoprostol) Ferring Vaginal uncertain women who have an unfavorable cervix

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Non-Specialty Brand Drugs Pipeline — New Formulations TBA = to be announced † indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Route of Ad- FDA Filing / Drug Name Manufacturer Indication(s) / Use ministration Approval / Market Date Afrezza (insulin human [rDNA origin] inhalation MannKind Inhalation Type 1 & type 2 diabetes approved† powder) Bunavail BioDelivery Oral Opioid dependence approved† (buprenorphine/naltrexone) Epanova (eicosapentaenoic Omthera, Oral High triglycerides approved† acid/docosahexaenoic acid) AstraZenca Ximino (minocycline ER) Ranbaxy Oral Moderate to severe acne approved† Zecuity (sumatriptan trans- NuPathe Transdermal Migraine approved† dermal) TBA () Sanofi SubQ Type 1 & type 2 diabetes 3Q2014 Lecette (desogestrel/ Teva Oral Prevention of pregnancy JUL 2014 ethinyl estradiol) TBA (indomethacin submi- Iroko Oral Pain JUL 2014 cron) Moderate-to-severe acute Zalviso (sufentanil) AcelRx Sublingual JUL 2014 pain in hospital setting GlaxoSmith Alisade (fluticasone furoate) Inhalation Asthma AUG 2014 Kline Flamel Tech- Genvir (acyclovir) Oral Herpes simplex virus infection AUG 2014 nologies Contrave (naltrexone/ Orexigen, Oral Weight loss SEP 2014 bupropion ER) Takeda TBA (budesonide) Salix Rectal Mild to moderate ulcerative colitis SEP 2014 RedHill TBA (rizatriptan) BioPharma, Oral Acute migraine SEP 2014 IntelGenX Zerenex (ferric citrate coordi- Hyperphosphatemia in Keryx, Panacor Oral SEP 2014 nation complex) end-stage renal disease Natpara (recombinant human NPS, Takeda SubQ Hypoparathyroidism OCT 2014 ) Rytary (carbidopa/ levodopa) Impax Oral Parkinson’s disease OCT 2014 TBA (liraglutide) Novo Nordisk SubQ Weight management OCT 2014 Rasuvo () Medac SubQ Rheumatoid arthritis, psoriasis NOV 2014 Rextoro Clarus Thera- Oral Testosterone deficiency NOV 2014 (testosterone undecanoate) peutics OptiNose, TBA (sumatriptan intranasal) Nasal Acute treatment of migraine NOV 2014 Avanir CompleoTRT Trimel Nasal Male hypogonadism 2014 (testosterone intranasal) GeNOsyl MVG-2000 (nitric GeNO Inhalation Hypoxic respiratory failure in neonate 2014 oxide delivery system) Humalog () Eli Lilly SubQ Type 1 & Type 2 diabetes 2014 Map, Nektar, Levadex () Inhalation Migraine 2014 Allergan MoxDuo IR (mor- RxPharma, New oral formulation for Oral 2014 phine/oxycodone) Actavis moderate to severe acute pain Acorda Thera- Plumiaz (diazepam) Nasal Seizures 2014 peutics TBA Neos Thera- Oral ADHD 2014 (amphetamine polistirex) peutics TBA (granisetron SR) AP Pharma SubQ Chemotherapy-induced nausea & vomiting 2014 TBA (norethindrone trans- Actavis Topical Prevention of pregnancy 2014 dermal delivery system) TBA (levetiracetam ER) Sun Oral Epilepsy 2014 Ventrus, SLA Anoheal () Topical Pain associated with anal fissure 2Q2014 (filing*) Pharma Toujeo (insulin glargine) Sanofi SubQ Type 1 & type 2 diabetes 2Q2014 (filing*)

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Abuse-deterrent treatment of TBA (benzhydrocodone) KemPharm Oral 3Q2014 (filing*) moderate to severe pain Androxal Repros Oral Secondary hypogonadism 4Q2014 (filing*) (enclomiphene citrate) Spiriva Respimat Boehringer Inhalation COPD 4Q2014 (filing*) (tiotropium bromide) Ingelheim 4Q2014 Sustol (granisetron SR) Heron SubQ Chemotherapy-induced nausea & vomiting (re-filing*) TBA (glycopyrronium bro- Novartis Inhalation Moderate to severe COPD 4Q2014 (filing*) mide/indacaterol) TBA Cephalon, Oral Abuse-deterrent treatment of chronic pain 4Q2014 (filing*) (hydrocodone bitartrate ER) Teva TBA (morphine ER) Egalet Oral Abuse-deterrent treatment of chronic pain 4Q2014 (filing*) TBA (oxycodone ER) Collegium Oral Abuse-deterrent treatment of chronic pain 4Q2014 (filing*) TherapeuticsM 4Q2014 – 2015 TBA () Oral Secondary amenorrhea D (filing) Seebri Breezhaler Vectura, No- 4Q2014 – 2016 (glycopyrronium bromide Inhalation Asthma, COPD vartis (filing*) long-acting) Ameluz (5-aminolevulinic Biofrontera Topical Actinic keratosis 2014 (filing*) acid nanocolloidal) Neuropathic pain associated with Amiket (keta- chemotherapy-induced peripheral EpiCept Topical 2014 (filing*) mine/) neuropathy in patients previously treated with -based chemotherapy Asacard Flamel, Secondary prevention of Oral 2014 (filing*) (acetylsalicylic acid) NewHaven cardiovascular disease Pain, swelling, & inflammation Bromsite (bromfenac) InSite Vision Ophthalmic 2014 (filing*) associated with ocular surgery CCP-01 Tris, Vernalis Oral Cough, cold 2014 (filing*) Ventrus Bio- Dolizem (diltiazem) sciences, SLA Topical Pain associated with anal fissures 2014 (filing*) Pharma Proair Spiromax (albuterol) Teva Inhalation Asthma 2014 (filing*) Relistor Opioid-induced constipation Salix SubQ 2014 (filing*) (methylnaltrexone bromide) in chronic pain Symbicort AstraZeneca Inhalation Asthma, COPD 2014 (filing*) (budesonide/formoterol) TBA (carvedilol CR) RedHill Oral Hypertension, heart failure 2014 (filing*) Insys TBA (dronabinol) Oral Chemotherapy-induced nausea & vomiting 2014 (filing*) Therapeuics Iron deficiency anemia associated with in- TBA (ferric trimaltol) Vitra, Shield Oral 2014 (filing*) flammatory bowel disease TBA (lidocaine/prilocaine) Piethora Topical Premature ejaculation 2014 (filing*) Lightlake TBA () Nasal Binge eating disorder 2014 (filing*) Therapeutics Prevention of nausea & vomiting TBA (ondansetron) RedHill Oral 2014 (filing*) in cancer patients TBA (tadalafil) IntelGenX Oral Erectile dysfunction 2014 (filing*) Glax- TBA (vilanterol) oSmithKline, Inhalation COPD 2014 (filing*) theravance Vycavert (hydrocodone/ Acura Oral Moderate to severe pain 2014 (filing*) acetaminophen) Zubsolv (buprenorphine/ Orexis Sublingual Opioid dependence 2014 (filing*) naloxone) Bema LA BioDelivery, 2014 – 2015 (fil- Oral Moderate to severe chronic pain (buprenorphine buccal) Endo ing*) Viviant (bazedoxifene) Pfizer Oral Postmenopausal osteoporosis 2014 (re-filing*) Swedish Or- Orfadin (nitisinone) phan Oral Hereditary tyrosinemia type 1 2014 (re-filing*) Biovitrum TBA (cough/ 2014 – 2015 (fil- Tris, Vernalis Oral Cough, cold cold therapy ER) ing*) Visonac 2014 – 2015 (fil- Photocure Topical Acne (methyl aminoevulinate) ing*) 2014 – 2017 (fil- TBA () Janssen Nasal Depression ing*)

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TBA (insulin peglispro) Eli Lilly SubQ Type 1 and type 2 diabetes 1Q2015 FibroCaps (fibrino- The Medicines transdermal Hemostasis during surgery JAN 2015 gen/thrombin) Company TBA Purdue Oral Abuse-deterrent treatment of chronic pain FEB 2015 (hydrocodone bitartrate ER) Pfizer, Pain Remoxy (oxycodone con- Therapeutics Oral Moderate to severe chronic pain 2015 trolled-release) Durect Secondary hyperpara-thyroidism Rayaldy, Replidea (calcifediol) Cytochroma Oral associated with vitamin D insufficiency 1Q2015 (filing*) in patients with CKD TherapeuticsM Vagicap (estradiol) Vaginal Postmenopausal vulvar & vaginal atrophy 3Q2015 (filing*) D TBA (hydrocodone/ MAR – APR Mallinckrodt Oral Abuse-deterrent treatment of chronic pain acetaminophen ER) 2015 (filing*) APR 2015 – Acute & maintenance therapy of TBA (ramelteon) Takeda Sublingual MAR 2016 (fil- bipolar I disorder ing*) Gram negative bacterial respiratory TBA (amikacin) Bayer, Nektar Inhalation 4Q2015 (filing*) tract infections TherapeuticsM TBA (estradiol/progesterone) Oral Menopause symptoms 4Q2015 (filing*) D BIOD-Stable Glucagon (pre- Hypoglycemia caused by insulin overdose Biodel SubQ 2015 (filing*) mixed stable glucagon) or congenital hyperinsulinism Bydureon ( CR) AstraZeneca SubQ Type 2 diabetes 2015 (filing*) Delzicol (mesalamine DR) Actavis Oral Ulcerative colitis 2015 (filing*) Watson, Esmya (ulipristal acetate) Gedeon Rich- Oral Anemia associated with uterine leiomyomas 2015 (filing*) ter SLA Pharma, Incostop (phenylephrine) Rectal Fecal incontinence 2015 (filing*) Ventrus Tarsa Thera- Ostora (calcitonin/ peutics, Oral Postmenopausal osteoporosis 2015 (filing*) recombinant salmon) Unigene TBA (capsaicin) NeurogesX Topical Neuropathic pain 2015 (filing*) Highland TBA (methylphenidate ER) Oral ADHD 2015 (filing*) Therapeutics TBA (oxycodone) Egalet Oral Pain 2015 (filing*) TBA (rifamycin SV MMX) Cosmo Oral Gastroenteritis 2015 (filing*) TBA Lipocine Oral Male hypogonadism 2015 (filing*) (testosterone undecanoate) Tefina (testosterone) M et P Pharma Nasal Female sexual arousal disorder 2015 (filing*) Vibex QS T (testosterone) Antares SubQ Hypogonadism 2015 (filing*) 2015 – 2016 Tresiba () Novo Nordisk SubQ Type 1 & type 2 diabetes (re-filing*) Twirla (ethinyl estradi- Agile Thera- Transdermal Prevention of pregnancy 2016 ol/levonorgestrel) peutics Sucampo, Amitiza (lubiprostone) Oral Chronic idiopathic constipation 2016 (filing*) Takeda TBA () Cynapsus Sublingual Parkinson’s disease 2016 (filing*) TBA (clonidine) BioDelivery Topical Painful diabetic neuropathy 2016 (filing*) Intarcia Ther- TBA (exenatide SR) SubQ Type 2 diabetes 2016 (filing*) apeutics TBA KemPharma Oral Chronic pain 2016 (filing*) (hydromorphone prodrug) TBA Makindus Ophthalmic Stargardt’s disease 2017 (filing*) (echothiophate iodide) TBA (methylphenidate KemPharma, Oral ADHD 2017 (filing*) prodrug/ligand) Monosol Rx TBA (zucapsaicin/ Winston Topical Osteoarthritis uncertain ciscapsaicin)

15

SPECIALTY Specialty Generic Drugs Pipeline † indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Brand Brand Manufac- Route of Ad- Generic Name Indication(s) / Use Approval / Name turer ministration Market Date glatiramer acetate Copaxone Teva Injection MS 1Q2015 Bristol Myers entecavir Baraclude Oral Hepatitis B FEB 2015 Squibb Bristol-Myers efavirenz Sustiva Oral Antiviral MAR 2015 Squibb epinephrine Epipen Mylan Injection Anaphylactic reactions JUN 2015 Targretin Eisai Oral, Topical Cutaneous T-cell lymphoma JUL 2015 Tracleer Actelion Oral Pulmonary arterial hypertension NOV 2015 Gleevec Novartis Oral Cancers (CML, ALL, etc.) FEB 2016 abacavir/ Human immunodeficiency Epzicom GlaxoSmithKline Oral MAR 2016 lamivudine virus (HIV) infection lamivudine/ abacavir/ Trizivir ViiV Healthcare Oral HIV MAR 2016 zidovudine lopinavir/ Kaletra Abbott Oral Antiviral DEC 2016 ritonavir ritonavir Norvir AbbVie Oral HIV infection DEC 2016 abiraterone acetate Zytiga Janssen Oral Prostate cancer DEC 2016 Bristol-Myers atazanavir Reyataz Oral Antiretroviral JUL 2017 Squibb tadalafil Adcirca Synthon Oral Pulmonary arterial hypertension NOV 2017 tenofovir Viread Gilead Oral Antiviral JAN 2018 efavirenz/emtricitabine/ Atripla Gilead Oral Antiviral AUG 2018 tenofovir fentanyl Fentora Cephalon Buccal Breakthrough cancer pain OCT 2018

Specialty Brand Drugs Pipeline TBA = to be announced † indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Route of Ad- FDA Filing / Drug Name Manufacturer Indication(s) / Use ministration Approval / Market Date Cerdelga (eliglustat tartrate) Genzyme Oral Gaucher disease type 1 JUN 2014 JUN – JULY Elonva (corifollitropin alfa) Merck SubQ Infertility 2014 Anaplastic lymphoma kinase positive TBA (ceritinib) Novartis Oral (ALK+) metastatic 3Q – 4Q 2014 non-small cell lung cancer Cancers (Chronic lympocytic leukemia TBA () Gilead Sciences Oral AUG – SEP 2014 (CML), indolent Non-Hodgkin’s Lymphoma Glax- TBA (dolutegravir/ oSmithKline, Oral HIV OCT 2014 lamivudine/abacavir) Viiv, Shionogi Tybost (cobicistat) Gilead Oral HIV OCT 2014 Vitekta (elvitegravir) Gilead Sciences Oral HIV OCT 2014 Esbriet (pirfenidone) InterMune Oral Idiopathic pulmonary fibrosis NOV 2014 Faridak () Novartis Oral Multiple myeloma NOV 2014 Aeterna Growth hormone deficiency, Solorel (macimorelin acetate) Oral NOV 2014 Zentaris treatment of cachexia Bristol Myers TBA (asunaprevir) Oral Hepatitis C virus infection DEC 2014 Squibb Bristol Myers TBA (daclatasvir) Oral Hepatitis C virus infection DEC 2014 Squibb Boehringer TBA (faldaprevir) Oral Hepatitis C virus infection DEC 2014 Ingelheim TBA (veruprevir/ritonavir/ Enanta, AbbVie Oral Hepatitis C virus infection DEC 2014 ombitsavir/desabuvir)

16

TBA (apremilast) Celgene Oral Psoriatic arthritis 2Q2014 (filing*) TBA (dasabuvir) AbbVie Oral Hepatitis C 2Q2014 (filing*) TBA (ombitasvir) AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) TBA (veruprevir) AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) TBA (veruprevir/ritonavir/ AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) ombitasvir) APR 2014 – TBA (alisertib) Takeda Oral Peripheral T-cell lymphoma MAR 2015 (fil- ing*) TBA () Pfizer, Onyx Oral Metastatic breast cancer 3Q2014 (filing*) 3Q2014 Iressa (gefitinib) AstraZeneca Oral Non-small cell lung cancer (re-filing*) 3Q-4Q 2014 TBA (apricitabine) Avexa Oral Multidrug resistant HIV infection (filing*) Glaxo- Bosatria (mepolizumab) SubQ Severe uncontrolled refractory asthma 4Q2014 (filing*) SmithKline Regeneron, TBA (alirocumab) SubQ Cholesterol 4Q2014 (filing*) Sanofi Aventis 4Q2014 – TBA (lomibuvir) Vertex Oral Hepatitis C virus infection 1Q2015 (filing*) Cinquil (reslizumab) UCB SubQ Eosinophilic asthma 2014 (filing*) TBA (acolbifene) Endoceutics Oral Breast Cancer 2014 (filing*) TBA (avatrombopag) Eisai Oral Immune thrombocytopenic purpura 2014 (filing*) In combination with Zelboraf TBA (cobimetinib) Genentech Oral 2014 (filing*) for metastatic melanoma TBA (danoprevir) Roche Oral Hepatitis C virus infection 2014 (filing*) TBA (drisapersen) Prosensa SubQ Duchenne muscular dystrophy (DMD) 2014 (filing*) TBA (eteplirsen) AVI BioPharma -- Duschenne muscular dystrophy 2014 (filing*) TBA (lenvatinib mesylate) Eisai Oral Endometrial cancer, thyroid cancer 2014 (filing*) Cystic fibrosis homozygous for TBA (lumacaftor) Vertex Oral 2014 (filing*) F508del CFTR mutation Cystic fibrosis homozygous for TBA (lumacaftor/ivacaftor) Vertex Oral 2014 (filing*) F508del CFTR mutation Pharmasset, TBA (mericitabine) Oral Hepatitis C virus infection 2014 (filing*) Roche Amicus Thera- TBA (migalastat) peutics, Glaxo- Oral Fabry disease 2014 (filing*) SmithKline TBA (sonidegib/erismodegib) Novartis Oral Advanced basal cell carcinoma 2014 (filing*) ACT Biotech, TBA (telatinib) Oral Gastric cancer 2014 (filing*) Bayer TBA (tildrakizumab) Merck SubQ Psoriasis >2014 (filing*) Boehringer 2014 – 2015 TBA (deleobuvir) Oral Hepatitis C virus infection Ingelheim (filing*) TBA 2014 – 2015 Hospira SubQ Anemia associated with CKD & cancer (erythropoietin biosimilar) (filing*) Eleison,Thresh- 2014 – 2015 TBA (glufosfamide) old Pharma- IV Pancreatic cancer (filing*) ceuticals 2014 – 2015 TBA (momelotinib) Gilead Sciences Oral Myelofibrosis (filing*) Pyoderma gangrenosum, 2014 – 2016 TBA (gevokizumab) Xoma SubQ non-infectious uveitis, Behcet’s disease (filing*) JNJ-56914845 (GSK- 2014 – 2017 (fil- Janssen Oral Chronic hepatitis C 2336805, GSK-805) ing*) 2014 – 2017 (fil- TBA (guselkumab) Janssen SubQ Psoriasis, rheumatoid arthritis ing*) Janssen, 2014 – 2017+ TBA (sirukumab) GlaxoSmith SubQ Rheumatoid arthritis, lupus nephritis (filing*) Klein Boehringer Idiopathic pulmonary fibrosis; Vargatef (nintedanib) Oral 1Q2015 – 2016+ Ingelheim non-small cell lung cancer; ovary tumor TBA (secukinumab) Novartis SubQ; IV Moderate to severe plaque psoriasis JAN 2015 Bristol Myers TBA (atazanavir/cobicistat) Squibb, Oral HIV FEB 2015 Gilead Sciences TBA (darunavir/cobicistat) Janssen, Gilead Oral HIV FEB 2015

17

Firdapse Catalyst Oral Lambert-Eaton myasthenic syndrome 1Q2015 (filing*) ( phosphate) TBA (daclatasvir/asunaprevi/ Bristol Myers Oral Hepatitis C virus infection 1Q2015 (filing*) beclabuvir) Squibb AZD-9291 AstraZeneca Oral Non-small cell lung cancer 2015 (filing*) CO-1686 Clovis, Celgene Oral Non-small cell lung cancer 2015 (filing*) Recentin (cediranib) AstraZeneca Oral Ovarian cancer 2015 (filing*) Acute myeloid leukemia, Rydapt (midostaurin) Novartis Oral 2015 (filing*) aggressive systemic mastocytosis Bristol Myers TBA (beclabuvir) Oral Hepatitis C virus infection 2015 (filing*) Squibb Amgen, Astra- TBA (brodalumab) SubQ Moderate to severe plaque psoriasis 2015 (filing*) Zeneca TBA (elbasvir) Merck Oral Chronic hepatitis C 2015 (filing*) TBA (grazoprevir) Merck Oral Chronic hepatitis C 2015 (filing*) TBA (ledipasvir) Gilead Sciences Oral Hepatitis C virus infection 2015 (filing*) Sanofi Aventis, Rheumatoid arthritis, TBA (sarilumab) SubQ 2015 (filing*) Regeneron ankylosing spondylitis Active Biotech, TBA (tasquinimod) Oral Metastatic castrate-resistant prostate cancer 2015 (filing*) Ipsen Taiho Pharma- TBA (trifluridine/tipiracil) Oral Metastatic colorectal cancer 2015 (filing*) ceutical Bone loss disorders, including postmeno- 2015-2016 (fil- TBA (romosozumab) UCB, Amgen SubQ pausal osteoporosis and bone fractures ing*) 2015 – >2017 TBA (buparlisib) Novartis Oral Breast cancer & solid tumors (filing*) ACH-3102 Achillion Oral Chronic hepatitis C 2Q2016 (filing*) TBA (sovaprevir) Achillion Oral Chronic hepatitis C 2Q2016 (filing*) TG-4010 Transgene SubQ Non-small cell lung cancer 2Q2016 (filing*) LCI-699 Novartis Oral Cushing’s disease 2016 (filing*) LEE-011 Novartis Oral Metastatic breast cancer 2016 (filing*) Proellex-V Severe menstrual bleeding associated Repros Oral 2016 (filing*) (telapristone acetate) with uterine fibroids TBA (benralizumab) AstraZeneca SubQ Severe uncontrolled asthma 2016 (filing*) TBA (binimetinib) Novartis Oral NRAS melanoma 2016 (filing*) TBA Novartis Oral BRAF mutant melanoma 2016 (filing*) (binimetinib/encorafenib) Hyperlipidemia, dyslipidemia, & heterozy- TBA (bococizumab) Pfizer SubQ 2016 (filing*) gous familial hypercholesterolemia TBA (defactinib) Verastern Oral Mesothelioma 2016 (filing*) TBA (dovitinib) Novartis Oral Renal cell cancer 2016 (filing*) TBA (encorafenib) Novartis Oral BRAF mutant melanoma 2016 (filing*) TBA (lebrikizumab) Genentech SubQ Asthma 2016 (filing*) Rheumatoid arthritis, asthma, amyotrophic TBA (masitinib) AB Science Oral lateral sclerosis, gastrointestinal stromal 2016 (filing*) tumor Pharmasset, TBA (mericitabine) Oral Chronic hepatitis C 2016 (filing*) Roche TBA () AstraZeneca Oral BRCA-mutated ovarian cancer 2016 (filing*) Cell Therapeu- TBA (pacritinib) Oral Myelofibrosis 2016 (filing*) tics TBA (setrobuvir) Roche Oral Hepatitis C virus infection 2016 (filing*) AbbVie, Genen- TBA () Oral Chronic lymphocytic leukemia 2016 (filing*) tech, Roche PTC Therapeu- Nonsense mutation duchenne muscular Translarna (ataluren) Oral 2016 (filing*) tics dystrophy TBA Metastatic gastric or gastroesophageal junc- Genentech Oral >2016 (filing*) (ipatasertib dihydrochloride) tion cancer 2016 – 2017 (fil- FSH-GEX, GT-GP 2.4 GEX Glycotype SubQ Infertility ing*) TBA (selumetinib) AstraZeneca Oral KRAS+ non-small cell lung cancer 2017 (filing*) BGJ-398 Novartis Oral Solid tumors >2017 (filing*) BYL-719 Novartis Oral Solid tumors >2017 (filing*) TBA (alisporivir) Novartis Oral Hepatitis C virus infection >2017 (filing*) TBA (dactolisib) Novartis Oral Solid tumors >2017 (filing*) TBA (quilizumab) Novartis SubQ Allergic diseases >2017 (filing*) TBA (siponimod) Novartis Oral Secondary progressive MS >2017 (filing*)

18

Specialty Brand Drugs Pipeline — New Formulations TBA = to be announced † indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Route of Ad- FDA Filing / Drug Name Manufacturer Indication(s) / Use ministration Approval / Market Date Plegridy Biogen Idec SubQ Relapsing forms of MS AUG 2014 (peginterferon beta-1a) Hyqvia (immunoglobulin Baxter, [human]/hyaluronidase [hu- SubQ Primary immunodeficiency in adults SEP 2014 Halozyme man, recombinant]) Nova, Rare Xaluprine () Disease Thera- Oral Acute lymphoblastic leukemia 4Q2014 peutics Improved tablet formulation for kidney Envarsus (tacrolimus) Veloxis Oral OCT 2014 transplant rejection prevention Pharmacyclics, Chronic lymphocytic leukemia, Imbruvica (ibrutinib) Oral OCT 2014 Janssen small lymphocytic leukemia TBA (sofosbuvir/ledipasvir) Gilead Oral Hepatitis C virus infection OCT 2014 Concentrated formulation for Kalbitor (ecallantide) Dyax SubQ 2014 hereditary angioedema Pan Pharma- ceuticals Har- TBA vest Moon SubQ Neutropenia 2014 (filgrastim biosimilar) Pharmaceuti- cals Lonquex (lipegfilgrastim) Teva SubQ Chemotherapy-induced neutropenia 2014 TBA (treprostinil United Thera- Oral Pulmonary arterial hypertension 2014 diethanolamine) peutics Biogen Idec, TBA (daclizumab) SubQ Relapsing remitting MS 4Q2014 (filing*) AbbVie Gram-negative lung infections caused by Arikace Insmed, pseudomonas aeruginosa in patients with Inhalation 2014 (filing*) (amikacin liposomal) Transave cystic fibrosis & bronchiectasis, non- tuberculous mycobacteria lung infections Kalydeco (ivacaftor) Vertex Oral Cystic fibrosis 2014 (filing*) Chiasma, Octreolin (ocreotide acetate) Oral Acromegaly 2014 (filing*) Roche TBA (caplacizumab) Ablynx SubQ Thrombotic thrombocytopenic purpura 2014 (filing*) Gilead Scienc- TBA (tenofovir alafenamide) Oral HIV in treatment-naïve adults 1Q2015 (filing*) es TBA (ciprofloxacin dry pow- Chronic pseudomonas aeruginosa lung in- Bayer, Nektar Inhalation 4Q2015 (filing*) der inhalation) fections in bronchiectasis BA-058, BIM-44058, Redium SubQ Postmenopausal osteoporosis 2015 (filing*) ITM-058 Health, Teijin for LAR (pasireotide) Novartis SubQ Cushing’s syndrome 2015 (filing*) TBA (growth hormone) Prolor Biotech SubQ Growth hormone deficiency 2015 (filing*) TBA (peginterferon Bristol Myers Hepatitis B virus infection, SubQ >2015 (filing*) lambda-1a) Squibb hepatitis C virus infection Phenylase ( BioMarin SubQ Phenylketonuria 1Q2016 (filing*) hydroxylase) Baxter, TBA Daiichi SubQ Rheumatoid arthritis 2016 (filing*) (etanercept biosimilar) Sankyo, Coherus

References:

1. Pharmacist’s Letter, Anticipated Availability of First-Time Generics, Therapeutic Research Center, 3120 W. March Lane, PO Box 8190, Stockton, CA 95208, Copy- right © 1995-2014, All rights reserved, last accessed 3/25/2014, http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?nidchk=1&cs=&s=PL&dd=290111&pb=&pt=2&fpt=55&menu=ftg 2. Rx Outlook: Generic Pipeline December 2013-December 2016, SXC Drug Information Services, 2013 SXC Health Solutions, Inc. Volume 7, Issue 12, 4th Quarter 2013 3. Rx Outlook: Generic Pipeline June 2014 to June 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 4, 2nd Quarter 2014 4. Rx Outlook: Generic Pipeline March 2014 to March 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 1, 1st Quarter 2014 5. Rx Outlook: Non-specialty pipeline – Q1 2014 to 2018, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 2, 1st Quarter 2014 6. Rx Outlook: Non-specialty pipeline – Q4 2013 to 2017, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 13, 4th Quarter 2013 7. Rx Outlook: Non-specialty pipeline – 2014 to 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 5, 2nd Quarter 2014 8. Rx Outlook: Specialty pipeline – Q1 2014 to 2018, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 3, 1st Quarter 2014 9. Rx Outlook: Specialty pipeline – Q4 2013-2017, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 13, 4th Quarter 2013 10. Rx Outlook: Specialty pipeline – 2014 to 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 6, 2nd Quarter 2014 19

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