July Through September 2013

July through September 2013

infections, complications of infection, or other underlying Updated Warnings—Current Drugs medical conditions. (9/27/13)

FDA Warning: Budesonide Solution: The FDA New Boxed Warning for Intravenous Tygacil – alerted patients and healthcare providers that budesonide Increased Risk of Death: The FDA is warning that an solution—for the maintenance treatment of asthma and as additional analysis shows an increased risk of death when prophylactic therapy in children 12 months to 8 years of intravenous (IV) Tygacil (tigecycline) is used for FDA- age—from The Compounding Shop may be contaminated approved uses as well as for non-approved uses. As a and should not be used or administered to patients. The result, we approved a new Boxed Warning about this risk to FDA observed a 1000mL bottle of budesonide solution be added to the Tygacil drug label and updated the from The Compounding Shop that contained visible, white, Warnings and Precautions and the Adverse Reactions floating material; the material was identified as a fungus sections. A Boxed Warning is the strongest warning given which may be present in other budesonide solution to a drug. These changes to the Tygacil label are based on products from The Compounding Shop that may currently an additional analysis that was conducted for FDA- be on the market. FDA is alerting healthcare providers to approved uses after issuing a Drug Safety Communication immediately quarantine any budesonide solution products (DSC) about this safety concern in September 2010. from The Compounding Shop and not administer them to Health care professionals should reserve Tygacil for use in patients. (9/27/13) situations when alternative treatments are not suitable.

Tygacil is FDA-approved to treat complicated skin and skin Hepatitis B Reactivation from Arzerra and structure infections (cSSSI), complicated intra-abdominal Rituxan: The FDA approved changes to the prescribing infections (cIAI), and community-acquired bacterial information of the immune-suppressing and anti-cancer pneumonia (CABP). Tygacil is not indicated for treatment drugs Arzerra (ofatumumab) and Rituxan (rituximab) to of diabetic foot infection or for hospital-acquired or add new Boxed Warning information about the risk of ventilator-associated pneumonia. Patients and their reactivation of hepatitis B virus (HBV) infection. The caregivers should talk with their health care professionals if revised labels also will include additional they have any questions or concerns about Tygacil. recommendations for screening, monitoring, and In the 2010 DSC, we informed the public that a combined managing patients on these drugs to decrease this risk. analysis, or meta-analysis, of 13 Phase 3 and 4 trials Both Arzerra and Rituxan are used to treat certain cancers showed a higher risk of death among patients receiving of the blood and lymph system. Rituxan is also approved to Tygacil compared to other antibacterial drugs: 4.0% treat other medical conditions, including rheumatoid (150/3788) vs. 3.0% (110/3646) respectively. The adjusted arthritis. Both drugs suppress the body's immune system. risk difference for death was 0.6% with corresponding 95% In patients with prior HBV infection, HBV reactivation may confidence interval (0.1, 1.2). The increased risk was occur when the body’s immune system is impaired. This greatest in patients treated with Tygacil for ventilator- infection can cause serious liver problems, including liver associated pneumonia, a use for which FDA has not failure and death. Reactivation can occur in patients who approved the drug. previously had HBV infection that was clinically resolved Since issuing the 2010 DSC, we analyzed data from 10 but who later require therapy for a condition such as clinical trials conducted only for FDA-approved uses cancer. When a treatment is given that can impair the (cSSSI, cIAI, CABP), including trials conducted after the body’s immune system, the previous HBV infection can drug was approved. This analysis showed a higher risk of again become an active infection. The initial HBV infection death among patients receiving Tygacil compared to other may occur without obvious signs of liver disease, and it antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), may remain dormant in liver tissue; therefore, screening respectively. The adjusted risk difference for death was for evidence of prior exposure is necessary to reliably 0.6% with corresponding 95% confidence interval (0.0%, assess the risk of HBV reactivation. (9/25/13) 1.2%). In general, the deaths resulted from worsening

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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 Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang: (JC) virus that damages the fatty covering of the brain The FDA is advising consumers not to purchase or use called myelin. PML usually causes death or severe “收腹提臀果香型减肥胶囊 ”or “Shou Fu Ti Tun Guo Xiang disability. Xing Jian Fei Jiao Nang” (translates – Abdomen Hips Fruit Patients should not stop taking Gilenya without first Flavored Slimming Capsules) also known as “Сокращать discussing any questions or concerns with their healthcare живот и повышать 3ад” (translates – Reducing Belly and professionals. The FDA is providing this alert while Lifting the Buttocks). FDA laboratory analysis confirmed continuing to investigate the PML case and is working with that Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang Gilenya’s manufacturer, Novartis, to obtain and review all contains sibutramine. Sibutramine is a controlled available information about this occurrence. The FDA will substance that was removed from the market in October communicate its final conclusions and recommendations 2010 for safety reasons. The product poses a threat to after the evaluation is complete. (8/29/13) consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients Ortiga – Unapproved Product: The FDA is advising and may present a significant risk for patients with a consumers not to purchase or use Ortiga, an unapproved history of coronary artery disease, congestive heart failure, product promoted for a variety of health conditions and arrhythmias, or stroke. This product may also interact, in sold on multiple websites (including eBay) and in some life-threatening ways, with other medications a consumer retail stores. The product is manufactured in Mexico and may be taking. Laboratory analysis also confirmed that labeled primarily in Spanish. Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang FDA laboratory analysis confirmed that Ortiga contains the contains phenolphthalein. Phenolphthalein was an prescription drug ingredient, diclofenac. Diclofenac is a ingredient in some over-the-counter (OTC) laxative non-steroidal anti-inflammatory drug (commonly referred products until 1999, when FDA reclassified the ingredient to as an NSAID). NSAIDs may cause increased risk of as “not generally recognized as safe and effective.” cardiovascular events—such as heart attack and stroke—as This product is promoted and sold for weight loss on well as serious gastrointestinal damage—including various websites, including www.instantslim.org, and in bleeding, ulceration, and fatal perforation of the stomach some retail stores. Consumers should stop using this and intestines. This hidden drug ingredient may also product immediately and throw it away. Consumers who interact with other medications and significantly increase have experienced any negative side effects should consult a the risk of adverse events, particularly when consumers use healthcare professional as soon as possible. (9/17/13) multiple NSAID-containing products. Consumers should stop using this product immediately and Additional Warning on Tylenol: The makers of dispose of the remainder. Consumers should consult a Tylenol—a medication that temporarily a) reduces fever healthcare professional as soon as possible if they have and b) relieves minor aches and pains due to the common experienced any negative side effects such as unusually cold, flu, headache, sore throat, or toothache—are placing dark stools or urine, stomach pain, increased bruising, or the word “acetaminophen” on the caps of product other signs of bleeding. (8/22/13) containers in order to remind consumers that acetaminophen is the #1 cause of sudden liver failure in the Fluoroquinolone Antibiotics Safety Risk— US. Acetaminophen is also found in hundreds of other Possibility of Nerve Damage: The FDA has required over-the-counter products that are used by many the drug labels and Medication Guides for all Americans, including Nyquil and Excedrin. fluoroquinolone antibacterial drugs be updated to better Acetaminophen overdoses account for tens of thousands of describe the serious side effect of peripheral neuropathy. emergency room visits and hundreds of deaths each year. This serious nerve damage potentially caused by (9/3/13) fluoroquinolones may occur soon after these drugs are taken and may be permanent. Gilenya (fingolimod) & Rare Brain Infection: The The risk of peripheral neuropathy occurs only with FDA is alerting the public that a patient in Europe fluoroquinolones that are taken by mouth or by injection. diagnosed with possible multiple sclerosis (MS)—a nervous Approved fluoroquinolone drugs include levofloxacin system disease that affects the brain and spinal cord—has (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), developed a rare and serious brain infection after taking norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin the drug Gilenya (fingolimod). [Gilenya is indicated for the (Factive). The topical formulations of fluoroquinolones, treatment of patients with relapsing forms of MS to reduce applied to the ears or eyes, are not known to be associated the frequency of clinical exacerbations and to delay the with this risk. accumulation of physical disability.] Novartis reports that Make sure your patients know to contact you if they approximately 71,000 patients worldwide have been develop symptoms of peripheral neuropathy. Make sure treated with Gilenya. your patients receive the Medication Guide with every This is the first case of progressive multifocal prescription. If a patient develops symptoms of peripheral leukoencephalopathy (PML) reported following the neuropathy, the fluoroquinolone should be stopped, and administration of Gilenya to a patient who had not the patient should be switched to another, non- previously received Tysabri (natalizumab), an MS drug fluoroquinolone antibacterial drug, unless the benefit of associated with a higher risk of PML. PML is a rare and continued treatment with a fluoroquinolone outweighs the serious brain infection caused by the John Cunningham risk. (8/15/13) 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 side effects associated with the antimalarial drug Acetaminophen and Risk of Serious Skin mefloquine hydrochloride. A boxed warning, the most Reactions: The FDA notified healthcare professionals serious kind of warning about these potential problems, and patients that acetaminophen has been associated with has been added to the drug label. The FDA has revised the a risk of rare but serious skin reactions. Acetaminophen is patient Medication Guide dispensed with each prescription a common active ingredient to treat pain and reduce fever; and wallet card to include this information and the it is included in many prescription and over-the-counter possibility that the neurologic side effects may persist or (OTC) products. These skin reactions, known as Stevens- become permanent. The neurologic side effects can include Johnson Syndrome (SJS), toxic epidermal necrolysis dizziness, loss of balance, or ringing in the ears. The (TEN), and acute generalized exanthematous pustulosis psychiatric side effects can include feeling anxious, (AGEP), can be fatal. These reactions can occur with first- mistrustful, depressed, or having hallucinations. time use of acetaminophen or at any time while it is being Neurologic side effects can occur at any time during drug taken. Other drugs used to treat fever and pain/body aches use and can last for months to years after the drug is (e.g., non-steroidal anti-inflammatory drugs [NSAIDS] stopped or can be permanent. Patients, caregivers, and such as ibuprofen and naproxen) also carry the risk of healthcare professionals should watch for these side effects. causing serious skin reactions—which is already described If a patient develops neurologic or psychiatric symptoms in the warnings section of their drug labels. when using the drug to prevent malaria, the patient should This new information resulted from the agency’s review of contact the prescribing healthcare professional about an the FDA Adverse Event Reporting System (FAERS) alternative medication. The patient should not stop taking database and the medical literature to evaluate cases of mefloquine before discussing symptoms with the serious skin reactions associated with acetaminophen. It is healthcare professional. (7/29/13) difficult to determine how frequently serious skin reactions occur with acetaminophen due to the widespread use of the Nizoral (ketoconazole) and Potential Health Risks: drug, differences in usage among individuals (e.g., The FDA is taking several actions related to Nizoral occasional vs. long-term use), and the long period of time (ketoconazole) oral tablets, including: limiting the drug’s that the drug has been on the market; however, it is likely use, warning that it can cause severe liver injuries and that these events (i.e., SJS, TEN, and AGEP) occur rarely. adrenal gland problems, and advising that it can lead to Healthcare professionals should be aware of this rare risk harmful drug interactions with other medications. The and consider acetaminophen, along with other drugs FDA has approved label changes and added a new already known to have such an association, when assessing Medication Guide to address these safety issues. As a patients with potentially drug-induced skin reactions. Any result, Nizoral oral tablets should not be a first-line patient who develops a skin rash or reaction while using treatment for any fungal infection. Nizoral should be used acetaminophen or any other pain reliever/fever reducer for the treatment of certain fungal infections, known as should stop the drug and seek medical attention right endemic mycoses, only when alternative antifungal away. Anyone who has experienced a serious skin reaction therapies are not available or tolerated. with acetaminophen should not take the drug again and Nizoral tablets can cause liver injury (hepatotoxicity), should contact their healthcare professional to discuss which may potentially result in liver transplantation or alternative pain relievers/fever reducers. death. The FDA has revised the Boxed Warning, added a The FDA will require that a warning be added to the labels strong recommendation against its use (contraindication) of prescription drug products containing acetaminophen to in patients with liver disease and included new address the risk of serious skin reactions. The FDA will recommendations for assessing and monitoring patients also request that manufacturers add a warning about for liver toxicity. Nizoral tablets may cause adrenal serious skin reactions to the product labels of OTC insufficiency by decreasing the body’s production of acetaminophen drug products marketed under a new drug corticosteroids. Nizoral tablets may interact with other application and will encourage manufacturers of drug drugs a patient is taking and can result in serious and products marketed under the OTC monograph do the potentially life-threatening outcomes, such as heart rhythm same. (8/1/13) problems. Healthcare professionals should assess the liver status of Label Changes for Antimalarial Drug: Malaria is a the patient before starting oral ketoconazole, and monitor serious disease caused by a parasite that commonly infects serum ALT levels during treatment. Adrenal function mosquitoes, which then bite humans. It is a major cause of should be monitored in patients with adrenal insufficiency death worldwide but is less common in the United States. or with borderline adrenal function and in patients under The disease is a problem primarily in developing countries prolonged periods of stress (major surgery, intensive care, with warm climates. Persons who travel to these countries etc.). Review all concomitant medications for the potential may be at risk of malaria infection and should take drugs to for drug interactions with Nizoral tablets. (7/26/13) prevent or reduce that risk. People with malaria often experience fever, chills, and flu-like symptoms. Drugs Health Risks with Healthy Life Chemistry Vitamin must be taken to treat the disease if you have been infected, B Dietary Supplement: The FDA is warning consumers but may, themselves, have side effects. that they should not use or purchase Healthy Life The FDA is advising the public about strengthened and Chemistry By Purity First B-50, marketed as a vitamin B updated warnings regarding neurologic and psychiatric dietary supplement. A preliminary FDA laboratory 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 analysis indicated that the product contains two potentially this action include claims such as “prevents and treats harmful anabolic steroids—methasterone, a controlled diabetes,” and “can replace medicine in the treatment of substance, and dimethazine. These ingredients are not diabetes.” The FDA recently issued letters warning 15 listed in the label and should not be in a dietary companies that the sale of their illegally marketed diabetes supplement. products violates federal law. The FDA has requested a “Products marketed as a vitamin but which contain written response from these companies within 15 business undisclosed steroids pose a real danger to consumers days stating how the companies will correct the violations. and are illegal,” said Howard Sklamberg, director of Failure to promptly correct the violations may result in the Office of Compliance in the FDA’s Center for Drug legal action, including product seizure, injunction, and/or Evaluation and Research. “The FDA is committed to criminal prosecution. ensuring that products marketed as vitamins and The FDA is advising consumers not to use these or similar dietary supplements do not pose harm to consumers.” products because they may a) contain harmful ingredients, The FDA has received reports of 29 adverse incidents b) be otherwise unsafe, or c) improperly be marketed as associated with the use of Healthy Life Chemistry By Purity over-the-counter products when they should be marketed First B-50. These reports include fatigue, muscle as prescription products. Using these products could cause cramping, and myalgia (muscle pain)—as well as abnormal consumers to delay seeking proper medical treatment for laboratory findings for liver and thyroid function, and their diabetes. (7/23/13) cholesterol levels. Females who used this product reported unusual hair growth and missed menstruation, and males Recalls/Suspensions who used the product reported impotence and findings of low testosterone. Consumers using Healthy Life Chemistry 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 By Purity First B-50 who experience any of these symptoms information located at the end of the bulletin). should consult a healthcare professional and report their experience to the FDA. Using anabolic steroid-containing products may cause University Compounding Pharmacy Injection acute liver injury. Some of the cases reported have resulted Products Recall: University Compounding Pharmacy is in hospitalization, but there were no reports of death or voluntarily recalling products – including Testosterone acute liver failure. In addition, anabolic steroids may cause Cypionate (Sesame Oil), Testosterone Cypionate/ other serious long-term consequences in women, men, and Testosterone Proprionate, and PGE-1 NS, for injection – to children. These include adverse effects on blood lipid the consumer level. In a recent inspection, FDA levels, increased risk of heart attack and stroke, investigators observed that methods used by the masculinization of women, shrinkage of the testicles, breast Independent Third Party laboratory to assess sterility may enlargement, infertility in males, and short stature in have resulted in pharmacies receiving inaccurate children. (7/26/13) laboratory test results. The FDA has concerns that results obtained from the laboratory are not reliable. If there is Illegal Sales of Diabetes Treatments: The FDA is microbial contamination in products intended to be sterile, taking action to remove from the market illegal products— patients are at risk of serious infections which may be life- including some labeled as dietary supplements—that claim threatening. to mitigate, treat, cure, or prevent diabetes and related The prescription preparations were distributed nationwide complications. To date, the FDA is not aware of any from May 9, 2013 to September 7, 2013. The preparations reports of injury or illness associated with the illegally sold would have been sold directly to customers by pick up and products, but it is taking action to protect the public health by mail. Customers that have product which is being from potential harm related to these violative products. recalled should stop using it and contact University These illegally sold products include: Compounding Pharmacy to arrange for return of unused • products sold as “natural” treatments for diabetes but product. Customers with questions regarding this recall containing undeclared active pharmaceutical ingredients in can contact University Compounding Pharmacy at 1875 unknown quantities that could cause harm or complicate Third Ave, San Diego CA 92101 or 619-683-2005. (9/8/13) medical conditions; • dietary supplements and ayurvedic products (medicine of the Ophthalmic Solution [under Wal-Mart, CVS, and healing arts that originated in India) with claims to treat, Target Brands] Recall: Altaire Pharmaceuticals, Inc., cure, and/or prevent diabetes; • unapproved drugs sold over-the-counter (including some announced that it is voluntarily recalling a total of nine (9) homeopathic products) intended to treat complications lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic associated with diabetes—include relieving symptoms caused Solution, Sterile, 1 fl. oz. (30 mL) to the consumer level. by nerve damage in the arms and legs (also called peripheral Due to complaints of mold found in the bottles, concerns neuropathy); and regarding the effectiveness of the preservative after use and • prescription drugs for diabetes sold by online pharmacies handling of the product by consumers have prompted the without a prescription. recall. A product whose preservative may not be effective The FDA-approved diabetes treatments, prescribed by a could lead to the use of a contaminated product which licensed healthcare professional and shown to be safe and creates a potential risk for eye infection. effective, are readily available for people with diabetes. Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution Many of the illegally sold products that are the subject to is a non-prescription (OTC) drug product used to relieve 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 dryness of the eye and packaged in a plastic bottle inside a protective local inflammatory response to the foreign unit box. The product is labeled as follows: material and are typically non-serious. • equate Restore Tears Lubricant Eye Drops – distributed by Anyone with an existing inventory of the product lots listed Wal-Mart Stores, Inc in the firm's press release should determine whether they • Lubricant Eye Drops for Mild to Moderate Dry Eye – have product from the recalled lots, quarantine and distributed by CVS Pharmacy, Inc discontinue distribution of all recalled lots of the product, • Lubricant Eye drops for Mild to Moderate Dry Eye – and call Cubist at (855) 534-8309 between the hours of distributed by Target Corp Consumers who have the product with any of the lot 9am and 7pm EST, Monday through Friday, to arrange for numbers should stop use of the product immediately and return and replacement of affected lots. (8/29/13) return it to the place of purchase. Consumers with questions regarding this recall can contact Altaire Compounded Sterile Preparations Recall: Park Pharmaceuticals at 1-800-258-2471, Monday – Friday Pharmacy & Compounding Center is voluntarily recalling from 9am – 5pm ET. Consumers should contact their two lots of products for injection—Methylcobalamin physician or healthcare provider if they have experienced 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: any problems that may be related to taking or using this 12/10/2013 and Multitrace-5 Concentrate 10ml Amber drug product. (9/8/13) Vials Lot #05212013@20 Exp: 11/17/2013. In a recent inspection, the FDA investigators observed that methods Motrin Infants Drops Recall: McNeil Consumer used by the laboratory to assess sterility may have resulted Healthcare is voluntarily recalling three lots – in pharmacies receiving inaccurate laboratory test results. approximately 200,000 units – of Concentrated Motrin The FDA has concerns that results obtained from the Infants’ Drops Original Berry Flavor 1/2 fl oz bottles laboratory are not reliable. distributed in the United States. After releasing these three The prescription preparations were sold during June and lots into the market, tiny plastic particles (approximately 1 July of 2013 in California, Florida, New Mexico, and mm in size or about the size of a poppy seed) were Indiana. The products would have been sold directly to identified in a different product lot during manufacturing. customers (pick up and by mail) and to physician offices by It was determined that the particles originated in a prescription (pick up and by mail). Customers with shipment from a third party supplier of ibuprofen, the questions regarding this recall can contact Park Pharmacy active ingredient in Concentrated Motrin Infants’ Drops & Compounding Center [Monday through Friday, 9am to Original Berry Flavor 1/2 fl oz. Out of an abundance of 5pm PST] at 949-551-7195 or at [email protected]. caution, McNeil is voluntarily recalling the three lots Customers should contact their physician or healthcare released to the market made with the same batch of active provider if they have experienced any problems that may ingredient. McNeil is asking retailers to remove the be related to taking or using these preparations. Park affected lots from store shelves, and is asking consumers to Pharmacy & Compounding Center is notifying its stop using and dispose of any product they may have that is customers by phone and mail and is arranging for return of included in this recall. all recalled product lots. Customers that have product Concentrated Infants’ Motrin Drops Dye-Free Berry Flavor which is being recalled should stop using it and contact 1 fl oz is not included in this recall. Children’s or Adult Park Compounding to arrange for return of unused Motrin products are not included in this recall. (9/8/13) product. (8/27/13)

4 Cubicin (daptomycin for injection) Lots Recall: Wellness Pharmacy Products Recall: Wellness [Cubicin is indicated for the treatment of a) complicated skin Pharmacy, Inc. issued a nationwide voluntary recall of and skin structure infections and b) Staphylococcus aureus certain sterile products due to laboratory results indicating bloodstream infections (bacteremia), including those with microbial contamination. If there is microbial right-sided infective endocarditis caused by methicillin- contamination in medications intended to be sterile, susceptible and methicillin-resistant isolates. Cubicin is not patients are at risk of serious infections which may be life- indicated for the treatment of pneumonia nor left-sided threatening. To date, Wellness Pharmacy has not received infective endocarditis due to S. aureus.] any reports of adverse events related to this recall. [Please Cubist has notified customers by letter and phone of the see FDA website for lot numbers.] Recalled medications voluntary recall of four lots of Cubicin (daptomycin for were distributed to individual patients and to physician injection) due to the presence of particulate matter found offices nationwide. These liquid medications are in either in a number of vials from four lots shipped from May 2011 clear or amber sterile vials ranging in size from 1ml to to March 2013. The administration of glass particulate, if 50ml. The medications can be identified by the label on present in an intravenous drug, poses a potential safety risk each vial—which will have the name of the drug, strength to patients. Case reports suggest that sequelae of or concentration, lot number, use by date, and vial size. thromboembolism, some life-threatening (such as To return medication or request assistance related to this pulmonary emboli), may occur. Patients with preexisting recall, patients and physicians should contact Wellness condition of trauma or other medical condition that Pharmacy at 205-879-6551 or 800-227-2627 [Monday adversely affects the microvascular blood supply are at an through Friday, between 9am and 4pm CDT]. Patients increased risk. The administration of glass particulate can should contact their physician or healthcare provider if also lead to formation of granulomas, which represent a they have experienced any problems that may be related to taking these medications. (8/27/13) 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 supplement product sold under the name Jack Rabbit. JCB Laboratories Products Recall: JCB Laboratories FDA lab analysis of the product was found to contain issued a recall of six lots of sterile drug products to the user sildenafil and tadalafil, which are active ingredients of level due to concerns of sterility assurance following a FDA-approved drugs for erectile dysfunction (ED)— recent inspection by the FDA of Front Range Laboratories making Jack Rabbit an unapproved drug. The undeclared of Loveland, Colorado—one of the contract testing labs ingredients may interact with nitrates found in some used by JCB. If there is microbial contamination in prescription drugs such as nitroglycerin and may lower products intended to be sterile, patients are at risk for blood pressure to dangerous levels. Consumers with serious, potentially life-threatening infections. [Please see diabetes, high blood pressure, high cholesterol, or heart FDA website for lot numbers.] The recalled products were disease often take nitrates. Additionally, the product may distributed to outpatient dialysis clinics in multiple states cause side effects such as headaches and flushing. from July 8, 2013-Aug. 20, 2013. JCB has not received any Jack Rabbit Pack is marketed as a dietary supplement for reports of adverse events related to this recall to date. In sexual enhancement. It is packaged in 4-count blister the recent inspection of Front Range Labs, the FDA stated packs and distributed online and to retail stores it observed that methods used by Front Range to assess nationwide. Customers who have this product in their sterility and other qualities (e.g., strength and stability) possession should stop using it immediately and contact may have resulted in pharmacies receiving inaccurate their physician if they have experienced any problems that laboratory test results. may be related to taking this product. Consumers should Consumers should contact their physician or healthcare return any unused product to the retail location where it provider if they have experienced any problems that may was purchased or contact the manufacturer at be related to taking or using this drug product. JCB has JackRabbit4pack.com for a return address. (8/21/13) begun notifying its customers by telephone, email, fax and mail. To return product or request assistance related to Repackaged Products from Aidapak Services LLC this recall, users should contact JCB Laboratories at 316- Recall: Aidapak Services LLC is conducting a voluntary 773-0405 [Monday through Friday, between 8:00am and recall of specific unit dose repackaged products sent to 25 5:00pm CDT]. (8/27/13) hospital inpatient pharmacies in the states of Washington, Oregon, California, and Arizona for products listed on the Hardmenstore.com Recalls: Upon request of the FDA, company’s website. The firm voluntarily recalled these Hardmenstore.com is voluntarily recalling 1000 lots of products to the hospital/user level after learning of possible 72HP, Evil Root, and Pro Power Max at the consumer level. incorrect labeling which could involve OTC, prescription, According to representatives of the FDA, these three and dietary supplement products. Some of the products, if products have reportedly been found to contain amounts of incorrectly labeled, could result in patients receiving drugs the PDE-5 Inhibitor sildenafil; sildenafil is not listed on the that were not prescribed, which could result in allergic product labels. These products are intended to be used as reactions or other undesired effects. Pregnant women dietary and sexual supplements. 72HP is packaged in a could receive a drug that they should not take or, as a result single blister pack containing 1 dose. Evil Root is packaged of receiving an incorrect medication, patients may not in box containing a bottle of 6 pills. Pro Power Max is receive proper treatment of their disease or condition. This packaged in a single blister pack containing 1 dose. All lots may pose a serious or life-threatening risk to a patient’s of 72HP, Evil Root and Pro Power Max are included in this health. recall. 72HP can be identified by the yellow packaging with AidaPak shipped affected products to four states only: a black horse insignia. Evil Root can be identified by its Washington, Oregon, California, and Arizona. Products orange box with blue Chinese characters. Pro Power Max affected by this recall are limited to strip packs packaged can be identified by the black and red packaging with between May 1, 2013 and July 1, 2013, of single-use dosage flames on the bottom of the packaging. forms, intended specifically to be administered to hospital Sildenafil, an active ingredient in an FDA-approved drug patients while admitted to the hospital. All products for erectile dysfunction (ED), may interact with nitrates affected by this recall are stamped with AidaPak’s found in some prescription drugs such as nitroglycerin and packaging stamp. The potentially affected hospitals, may lower blood pressure to dangerous levels. Consumers emergency rooms, and clinics should stop distributing with diabetes, high blood pressure, high cholesterol, or immediately and quarantine the products. Hospitals that heart disease often take nitrates. Additionally, the product may have sent product to other hospital pharmacies or may cause side effects, such as headaches and flushing. clinics should contact them and make them aware of the Consumers and retailers that have the 72HP, Evil Root, or recall. If you dispense medication to patients being Pro Power Max supplements should stop using them discharged on an outpatient basis, please contact those immediately and contact a doctor if any of the side effects patients who may have received the impacted products. have been felt. Consumers with questions regarding this Patients who were given prescriptions by a hospital’s voluntary recall can email [email protected] outpatient pharmacy to be taken home should check the [Monday to Friday, 11am to 5pm, EST]. (8/27/13) name and pedigree number against the recalled list provided in the firm press release. (8/17/13) Jack Rabbit Dietary Supplement Recall: Jack Rabbit Inc. announced that it is conducting a voluntary NuVision Pharmacy Sterile Drug Products Recall: nationwide recall of one lot of the company's dietary The FDA is reminding healthcare providers about safety 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 concerns with all sterile drug products made and The following products are marketed as dietary distributed by NuVision Pharmacy of Dallas, Texas. supplements and are packaged in white plastic bottles: Healthcare providers should not administer any NuVision • B-50, 100 capsule bottles, lot numbers F03Q and C02R Pharmacy sterile products to patients because the products’ • Multi-Mineral, 200 capsule bottles, lot number 12-829 sterility is not assured. NuVision Pharmacy has repeatedly • Vitamin C, 200 capsule bottles, lot number E03Q declined to recall its sterile products, and the FDA cannot These recalled products were distributed nationwide via require the company to undertake such a recall. (8/16/13) the internet and through retail stores from July 2012 through June 2013. Immediately discontinue the use of Recall of Specialty Compounding Sterile these products and return them to the place of purchase. Products—Information Update: The US Food and (8/1/13) Drug Administration [FDA] and the Specialty Compounding, LLC is voluntarily recalling all lots of sterile Beacon Hill Medical Pharmacy/Rxtra Solutions medications within expiry. Note: an earlier version of this Products Recall: Beacon Hill Medical Pharmacy and the news release indicated that the recall applied to all FDA is notifying health professionals and consumers of the unexpired sterile compounded products dispensed since recall of all lots of certain sterile products. The FDA has May 9, 2013; however, the recall applies to any sterile raised a question of sterility assurance for the affected medication that has not reached its expiration date, products. Microbial contamination of products intended to including all strengths and dosage forms. (8/16/13) be sterile can lead to serious infections, which may be life- threatening. The products were distributed nationwide to Recall of Specialty Compounding Sterile Products: outlets including hospitals, clinics, and patients who have The FDA is alerting healthcare providers and patients of a received orders by directly placing phone calls or faxed voluntary nationwide recall of all products produced and prescriptions to the Beacon Hill Medical pharmacy facility distributed for sterile use by Specialty Compounding, LLC, in Southfield, Michigan. Cedar Park, TX. There have been recent reports of The list of sterile injectable products compounded by bacterial bloodstream infections potentially related to the Beacon Hill/Rxtra Solutions and under recall, in company's calcium gluconate infusions. All sterile use alphabetical order, organized by drug name and strength products produced and distributed by Specialty can be found in the firm's press release. The products can Compounding are being recalled and none of these be identified by lot numbers starting with code products should be used by patients or administered to 01012013@1 to 07262013@99. (8/1/13) patients. [According to information provided by the firm, the recalled products were distributed directly to patients Nova Max Glucose Test Strips Recall: Nova Diabetes nationwide, with the exception of North Carolina. Recalled Care initiated a voluntary recall of 21 lots of the Nova Max products were also distributed directly to hospitals and Glucose Test Strips distributed both in the USA and outside physicians’ offices in Texas.] Facilities, healthcare the continental USA. Nova Max Plus glucose meter kits providers and patients who have received the products that include test strips from the recalled lots are also since May 9, 2013 should immediately discontinue use, included in this voluntary recall. quarantine the products and return the products to The company has recently determined that some of the Specialty Compounding. (8/11/13) blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus Benztropine Mesylate Injection Recall: A voluntary glucose meter kits may report a false, abnormally high recall was made by Nexus Pharmaceuticals Inc. for blood glucose result. A false abnormally high blood glucose benztropine mesylate injection 2 mg per 2 mL (1 mg/mL) result could, under certain conditions, result in an insulin in 2 mL single-dose vials; there is a potential presence of dosing error that could lead to a serious health risk visible particulate matter in the vials. This recall is at the requiring immediate medical attention. user level and includes 2 lots (030712, expiration date Those who use, recommend clinically, or sell Nova Max March 2014; 112911, expiration date November 2013). Glucose Test Strips for blood glucose testing should Healthcare professionals are advised to contact Nexus at 1- immediately discontinue using or distributing glucose test 888-806-4606 in order to return unused products. strips from the recalled lots. (7-29-13) (8/1/13) Silver Sword & Clalis Recalls: The manufacturer Healthy Life Chemistry by Purity First Products recalled 430 lots of Silver Sword and Clalis at the consumer Recall: Purity First Health Products is recalling two lots level. Silver Sword and Clalis have been found to contain of Healthy Life Chemistry B-50 (100 capsules), one lot of sildenafil, which could cause adverse reactions and drug Healthy Life Chemistry Multi-Mineral (200 capsules), and interactions normally associated with the active ingredient all lot numbers for Healthy Life Chemistry Vitamin C (200 in Viagra. Use of these products can result in decreased capsules). The B-50 capsules were found on testing by blood pressure, light-headedness, and dizziness. FDA to contain methasterone (a schedule III controlled The affected Silver Sword and Clalis lots include those substance) and dimethazine. Testing of the Multi-Mineral produced on or before April 2, 2013. The production date and Vitamin C capsules appear to indicate the presence of is stamped on the back of the packaging. dimethyltestosterone. These products are intended to be used as a dietary supplement and sexual supplement. Silver Sword is 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 packaged in a tin containing 8 doses, 2 pills per dose. 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the Clalis is packaged in box containing a bottle of 6 pills. potential presence of glass particles (glass delamination) in Consumers and retailers that have the Silver Sword or the vials. The defect discovered in this product was noted Clalis supplements should stop using this product as visible particulate; however, the process of glass immediately, and contact a doctor if any of the side effects delamination may result in formation of visible and have been felt. (7/22/13) subvisible particles. No adverse events, patient reactions or customer complaints have been reported to date. Estarylla Birth Control Recall—Presence of Benztropine mesylate is used as an adjunct in the therapy Placebo Tablets: Sandoz notified the public it is of all forms of Parkinsonism. It is also useful in the control conducting a voluntary nationwide recall to the retailer of extrapyramidal disorders due to neuroleptic drugs, level of one lot of its Estarylla (norgestimate and ethinyl except tardive dyskinesia. The company has discontinued estradiol) tablets in the US, following a customer report of distribution of benztropine mesylate while it investigates a placebo tablet present in a row of active tablets on one the cause. The product is manufactured by Allergy pack. Laboratories, Inc. and distributed by Fresenius Kabi USA. The lot number, expiration date, and NDC code of the The product may appear with "APP" or "Nexus recalled lot is: LF01213A, expiration date 02/2014, NDC Pharmaceuticals" labels. Recalled lot numbers include 00781-4058-15. It is supplied in cartons containing 3 030712, 071212, 090512 and 111412. blister cards of 28 tablets each. This lot was distributed to All customers who received the recalled vials are being the US market only. notified and instructed to return any unused product to Estarylla is indicated for the prevention of pregnancy in Fresenius Kabi USA. Healthcare professionals can find women who elect to use oral contraceptives as a method of additional information about the recall on the company's contraception. website (www.apppharma.com/our-products/product- The Sandoz Drug Information Direct Line is open at 800- updates3) or by calling Fresenius Kabi USA Quality 525-2492, 24 hours/day, and seven days a week. (7/5/13) Assurance at 1-866-716-2459, Monday through Friday, between the hours of 8am. and 5pm (Central Time). Menveo Recall: The FDA reported a voluntary recall of 1 Questions regarding product availability and ordering can lot of Menveo meningococcal (groups A, C, Y and W-135) be directed to Fresenius Kabi USA Customer Service at 1- oligosaccharide diphtheria CRM-197 conjugate vaccine by 888-386-1300, Monday through Friday, between the hours Novartis Vaccines. The recalled lot number—M12118 [Men of 7 a.m. and 6 p.m. (Central Time). (7/2/13) A vial Lot # A12118 and Men CWY vial lot # X12118]—came in response to reports of unusual amounts of residual Approved Drugs moisture within the lyophilized Men A component vial. The quantity of moisture should not affect the quality of the Please access www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm for in-depth drug approval information. product, and those patients receiving the vaccine from any lot in the past are required to take no action. (7/3/13) FDA Approves Treanda [injection]: The FDA Recombivax HB (Hepatitis B Vaccine approved an injectable version of Treanda. Treanda is a [Recombinant]) Recall: Potential for Cracked product of Pharmaceutical Industries Ltd. [NYSE: TEVA; Vials: Merck Sharp & Dohme Corp., a subsidiary of Merck TASE: TEVA] and is for treatment of a) chronic & Co., Inc. (Merck), initiated this voluntary recall due to lymphocytic leukemia (CLL) and b) indolent B-cell non- the potential for a limited number of cracked vials to be Hodgkin’s lymphoma (NHL) that has progressed during or present in the lot. Merck’s investigation concluded that for within 6 months of treatment with rituximab or a certain vials in the affected lot, the potential exists for a rituximab-containing regimen. (9/17/13) crack to have occurred in the vial. If the vial was cracked, the integrity of the vial and the sterility of any product Valchlor (mechlorethamine) Gel: The FDA approved remaining in the vial could not be assured. its first once-daily topical treatment for stage IA and IB Lot Number J001183 of RECOMBIVAX HB Adult mycosis fungoides-type cutaneous T-cell lymphoma. The Formulation is the only lot impacted by the recall and was gel formulation, under the name Valchlor and distributed solely within the United States. The lot was manufacturer by Ceptaris Therapeutics, is indicated in distributed by Merck between March 12, 2013 and May 2, patients who have received prior skin-directed therapy. 2013. There is adequate inventory to replace recalled Availability is scheduled toward the end of 2013. (8/23/13) product at this time. If product from this lot has been administered, Mirvaso for Erythema of Rosacea: The FDA has revaccination is not necessary. Customers are asked to approved Mirvaso (brimonidine) Topical Gel, 0.33%—an inventory and quarantine all products from Lot J001183 alpha adrenergic agonist, indicated for the topical and follow Merck’s instructions for return of product. treatment of persistent (nontransient) facial erythema of (7/3/13) rosacea in adults 18 years of age or older. This once-daily- use product by Galderma Laboratories is expected to arrive Benztropine Injections: Possible Presence of Glass in pharmacies within a month. (8/23/13) Particles Recall: Fresenius Kabi USA is voluntarily recalling four lots of Benztropine Mesylate Injection, USP, 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. 8 Trokendi XR for Seizures: The FDA approved Afatinib for Lung Tumors: The FDA approved afatinib Trokendi XR (topiramate) to treat: (Gilotrif tablets, Boehringer Ingelheim Pharmaceuticals, • Partial Onset Seizure and Primary Generalized Tonic-Clonic Inc.) for the first-line treatment of patients with metastatic Seizures – initial monotherapy in patients 10 years of age and non-small cell lung cancer (NSCLC) whose tumors have older with partial onset or primary generalized tonic-clonic epidermal growth factor receptor (EGFR) exon 19 deletions seizures and adjunctive therapy in patients 6 years of age and or exon 21 (L858R) substitution mutations as detected by older with partial onset or primary generalized tonic-clonic an FDA-approved test. The safety and efficacy of afatinib seizures • Lennox-Gastaut Syndrome (LGS) – adjunctive therapy in have not been established in patients whose tumors have patients 6 years of age and older with seizures associated with other EGFR mutations. Concurrent with this action,the Lennox-Gastaut syndrome FDA approved the therascreen EGFR RGQ PCR Kit The manufacturer, Supernus Pharmaceuticals, will release (QIAGEN) for detection of EGFR exon 19 deletions or exon the medication within the next month. (8/19/13) 21 (L858R) substitution mutations. The most frequent (≥20% incidence) adverse reactions New Drug for HIV Infection: The FDA approved from afatinib were diarrhea, rash/dermatitis acneiform, Tivicay (dolutegravir), a new drug to treat HIV-1 infection. stomatitis, paronychia, dry skin, decreased appetite, and Tivicay is an integrase strand transfer inhibitor that pruritus. Serious adverse reactions were reported in 29% interferes with one of the enzymes necessary for HIV to of patients treated with afatinib. The most frequent serious multiply. It is a pill taken daily in combination with other adverse reactions were diarrhea (6.6%), vomiting (4.8%); antiretroviral drugs. and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal Tivicay is approved for use in a broad population of HIV- adverse reactions in afatinib-treated patients included infected patients. It can be used to treat HIV-infected pulmonary toxicity/interstitial lung disease (ILD)-like adults who have never taken HIV therapy (treatment- adverse reactions (1.3%), sepsis (0.43%), and pneumonia naïve) and HIV-infected adults who have previously taken (0.43%). HIV therapy (treatment-experienced), including those who The recommended dose and schedule for afatinib is 40 mg have been treated with other integrase strand transfer orally once daily until disease progression or no longer inhibitors. Tivicay is also approved for children ages 12 tolerated by the patient. Afatinib should be taken at least years and older weighing at least 40 kilograms (kg) who are one hour before or two hours after a meal. (7/12/13) treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. Zubsolv for Opioid Dependence: The FDA approved a (8/12/13) medication to treat opioid dependence that will be used along with support services. Zubsolv (buprenorphine/ Lo Minastrin Fe for Pregnancy Prevention: The naloxone) is a maintenance drug that is taken sublingually FDA approved norethindrone acetate and ethinyl estradiol one time a day. (7/3/13) chewable tablets, ethinyl estradiol tablets, and ferrous fumarate tablets under the name of Lo Minastrin Fe for the Nymalize: The FDA gave approval to Arbor prevention of pregnancy. Because of possible Pharmaceuticals’ Nymalize, nimodipine oral solution, to cardiovascular events, this product should not be used by improve neurological results in adults who have a women smokers over the age of 35. (8/6/13) subarachnoid hemorrhage from a ruptured intracranial berry aneurysm, regardless of their postictus neurological Fetzima for Depression: The FDA approved Fetzima condition. Currently, nimodipine is also manufactured as a (levomilnacipran) for the treatment of major depressive liquid-filled gel capsule. (7/1/13) disorder. Fetzima is a serotonin and norepinephrine reuptake inhibitor taken one time a day. A Boxed Warning Brisdelle: Non-Hormonal Treatment for Hot is on the label concerning risk of suicidal thoughts and Flashes: The FDA today approved Brisdelle (paroxetine) behaviors. (7/25/13) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which Simponi Aria for Rheumatoid Arthritis: The FDA contains the selective serotonin reuptake inhibitor approved Simponi Aria (golimumab) infusion to treat paroxetine mesylate, is currently the only non-hormonal adults with moderately to severely active rheumatoid treatment for hot flashes approved by the FDA. There are a arthritis. It is to be used along with methotrexate. variety of FDA-approved treatments for hot flashes, but all Simponi Aria is manufactured by Janssen Biotech. contain estrogen alone or estrogen plus a progestin. (7/23/13) Hot flashes associated with menopause occur in up to 75 percent of women and can persist for up to five years, or Astagraf XL after Kidney Transplants: The FDA even longer in some women. Hot flashes are not life- approved Astagraf XL (tacrolimus) to prevent rejection threatening, but the symptoms can be very bothersome, after kidney transplant in patients with mycophenolate causing discomfort, embarrassment and disruption of mofetil and corticosteroids (with or without basiliximab sleep. induction). This extended-release medication comes in a The safety and effectiveness of Brisdelle were established in once-daily capsule and is manufactured by Astellas two randomized, double-blind, placebo-controlled studies Pharma. (7/19/13) in a total of 1,175 postmenopausal women with moderate to severe hot flashes (a minimum of seven to eight per day or 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. 9 50-60 per week). The treatment period lasted 12 weeks in who require continuous treatment of moderate to severe one study and 24 weeks in the other study. The results pain. (9/12/13) showed that Brisdelle reduced hot flashes compared to placebo. The mechanism by which Brisdelle reduces hot Generic Hepsera: The FDA has given Sigmapharm flashes is unknown. The most common side effects in Laboratories the official permission to proceed with release patients treated with Brisdelle were headache, fatigue, and of adefovir dipivoxil 10mg tablets (generic for Hepsera). nausea/vomiting. This medication is used to treat chronic hepatitis B virus in Brisdelle contains 7.5 mg of paroxetine and is dosed once select patients. (8/29/13) daily at bedtime. Other medications such as Paxil and Pexeva contain higher doses of paroxetine and are Generic Temodar Capsules: The FDA approved approved for treating conditions such as major depressive temozolomide 5, 20, 100, 140, 180, and 250 mg capsules disorder, obsessive-compulsive disorder, panic disorder (generic Temodar) by Teva Pharmaceuticals. This and generalized anxiety disorder. All medications that are medication treats a] newly diagnosed glioblastoma approved for treating depression, including Paxil and multiforme in adults who are also undergoing radiotherapy Pexeva, have a Boxed Warning about an increased risk of (can be used as maintenance treatment later) and b] suicide in children and young adults. Because Brisdelle refractory anaplastic astrocytoma in patients who were on contains the same active ingredient as Paxil and Pexeva, a a drug regimen containing nitrosourea and procarbazine Boxed Warning about suicidality is included in the and had disease progression. (8/12/13) Brisdelle label. Additional labeled warnings include a possible reduction in Esomeprazole Strontium for GERD: The FDA has the effectiveness of tamoxifen if both medications are used approved esomeprazole strontium delayed-release capsules together, an increased risk of bleeding, and a risk of for adults for the treatment of gastroesophageal reflux developing serotonin syndrome (signs and symptoms can disease—including healing of erosive esophagitis, include confusion, rapid heart rate, and high blood maintenance of healing of erosive esophagitis, and pressure). Brisdelle will be dispensed with a Medication symptomatic gastroesophageal reflux disease; risk Guide that informs patients of the most important reduction of nonsteroidal anti-inflammatory drug– information about the medication. The Medication Guide associated gastric ulcer; Helicobacter pylori eradication to will be distributed to patients each time the prescription is reduce the risk of duodenal ulcer recurrence (in refilled. (6/28/13) combination with amoxicillin and clarithromycin as triple therapy); and pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (8/6/13) New Generics Generic Tablet for Pregnancy Prevention: Mylan

Pharmaceuticals received approval from the FDA to Generic Vidaza: The FDA approved azacitidine—the distribute a generic version of Nor-Q.D.—Norethindrone generic for Vidaza. The product comes in injection form Tablets USP, 0.35mg. (7/16/13) (100 mg/vial) and is used for French-American-British

(FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts New Indications (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in Stelara: The FDA approved an additional treatment use transformation (RAEB-T), and chronic myelomonocytic for Stelara (ustekinumab), making two indications: leukemia (CMMoL). (9/16/13) 1) active psoriatic arthritis in patients ≥18 years (alone or in combination with methotrexate Generic Xeloda (capecitabine) Approved: The FDA 2) plaque psoriasis in candidates for phototherapy or approved the first generic version of Xeloda (capecitabine), systemic therapy who are ≥18 years an oral chemotherapy pill used to treat metastatic breast (9/20/13) cancer and cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body FluLaval – Influenza Virus Vaccine: The FDA (metastatic). Teva Pharmaceuticals USA has gained FDA approved the use of GlaxoSmithKline’s biologic product in approval to market generic capecitabine in 150 and 500 persons 3 years to 17 years of age for the prevention of milligram strengths. (9/16/13) influenza disease caused by influenza viruses contained in the vaccine. (8/16/13) Generic Opana ER: Oxymorphone hydrochloride extended-release tablets (5 mg, 10 mg, 20 mg, 30 mg, and FDA Expands Indication of Exelon Patch: The FDA 40 mg)—the generic equivalent of Opana ER—have been approved an expansion of the indication of Exelon Patches cleared for production through the manufacturer Actavis. (rivastigmine transdermal systems) to also treat severe [Actavis is currently marketing the 7.5mg and 15mg doses Alzheimer’s disease. Previously, Exelon Patches only of this product.] The medication is prescribed for patients treated dementia related to Parkinson’s disease and mild to moderate dementia of the Alzheimer’s type. (7/1/13)

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. 10 potent drugs that have harmed too many patients and Latuda: In addition to the prior use with schizophrenia, devastated too many families and communities,” said FDA Latuda (lurasidone hydrochloride) has been approved by Commissioner Margaret A. Hamburg, M.D. “Today’s action the FDA as monotherapy for the treatment of patients with demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended-release opioids while still seeking depressive episodes associated with bipolar I disorder to preserve appropriate access for those patients who rely on (bipolar depression) and as adjunctive therapy with lithium these medications to manage their pain.” or valproate. (6/28/13) Given the serious risks of using ER/LA opioids, the class- wide labeling changes, when final, will include important Revised Labeling/ new language to help healthcare professionals tailor their prescribing decisions based on a patient’s individual needs. Prescribing Information The updated indication states that ER/LA opioids are

indicated for the management of pain severe enough to Duragesic Packaging Changes: The FDA is requiring require daily, around-the-clock, long-term opioid color changes to the writing on Duragesic (fentanyl) pain treatment and for which alternative treatment options are patches so they can be seen more easily. [Duragesic is a inadequate. The updated indication further clarifies that, transdermal formulation of fentanyl indicated for the because of the risks of addiction, abuse, and misuse, even management of persistent, moderate to severe chronic pain at recommended doses, and because of the greater risks of in opioid-tolerant patients—those who are taking at least overdose and death, these drugs should be reserved for use 60mg of morphine daily, or at least 30mg of oral in patients for whom alternative treatment options (e.g., oxycodone daily, or at least 8mg of oral hydromorphone non-opioid analgesics or immediate-release opioids) are daily, or an equianalgesic dose of another opioid for a week ineffective, not tolerated, or would be otherwise inadequate or longer—2 years of age and older when a) a continuous, to provide sufficient management of pain; ER/LA opioid around-the-clock opioid analgesic is required for an analgesics are not indicated for as-needed pain relief. extended period of time and b) the patient cannot be (9/10/13) managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release Letairis—New Boxed Warning: The FDA has opioids.] In an effort to minimize the risk of accidental expanded the Boxed Warning for Letairis (ambrisentan) exposure to fentanyl patches, the FDA is requiring the from Gilead Sciences. It now states: manufacturer of Duragesic to print the name and strength Do not administer Letairis to a pregnant female of the drug on the patch in long-lasting ink and in a color because it may cause fetal harm. Letairis is very likely that is clearly visible to patients and caregivers. The to produce serious birth defects if used by pregnant current ink color varies by strength and is not always easy females, as this effect has been seen consistently when to see. This change is intended to enable patients and it is administered to animals. caregivers to more easily find patches on patients’ bodies Exclude pregnancy before the initiation of treatment and see patches that have fallen off, which children or pets with Letairis. Females of reproductive potential must could accidentally touch or ingest. The manufacturers of use acceptable methods of contraception during generic fentanyl patches are being requested to make treatment with Letairis and for one month after similar changes. treatment. Obtain monthly pregnancy tests during Patients and healthcare professionals are reminded that treatment and 1 month after discontinuation of fentanyl patches are dangerous even after they’ve been treatment. used because they still contain high amounts of strong Because of the risk of embryo-fetal toxicity, females narcotic pain medicine. Accidental exposure to these can only receive Letairis through a restricted program patches can cause serious harm and death in children, pets, called the Letairis REMS program. and others. The FDA continues to learn of deaths from (8/17/13) accidental exposure to fentanyl patches. Patients should be aware that patches that are not stuck to the skin tightly Menveo Vaccine Approved for Infants: The FDA enough may accidentally fall off a patient and stick to approved a vaccine against meningococcal disease that can someone in close contact, such as a child. Used fentanyl be administered from ages 2 months to 55 years. For patches require proper disposal after use—fold the patch, specifics, please access the Menveo website at sticky sides together, and flush it down the toilet right http://www.menveo.com/. (8/6/13) away. (9/23/13) Expanded Warning for Prozac: For Prozac (fluoxetine Opioid Analgesics—Various FDA-directed Changes: hydrochloride), the FDA expanded the previous warning— The FDA announced class-wide safety labeling changes and risk of suicidal thoughts and behavior with major new postmarket study requirements for all extended- depressive disorder and other psychiatric disorders—to release and long-acting (ER/LA) opioid analgesics intended include a) the medication is not approved for children less to treat pain. The new boxed warning will include neonatal than 7 years of age and b) when using the medication in opioid withdrawal syndrome. combination with olanzapine in combination, refer to “The FDA is invoking its authority to require safety labeling Boxed Warning section of the package insert for Symbyax. changes and postmarket studies to combat the crisis of (7/26/13) misuse, abuse, addiction, overdose, and death from these 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. 11 Olmesartan Label Changes: The FDA is warning that U.S. Food and Drug Administration’s the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) MedWatch Adverse Event Reporting Program can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include Please contact MedWatch to voluntarily report a serious adverse event, product quality problem, product use error, severe, chronic diarrhea with substantial weight loss. FDA or therapeutic failure that you suspect is associated with the has approved changes to the labels of these drugs to use of an FDA-regulated drug, biologic, medical device, die- include this concern. Sprue-like enteropathy has not been tary supplement or cosmetic. You can also report suspected detected with ARB drugs other than olmesartan. counterfeit medical products to the FDA through MedWatch. FDA will continue to evaluate the safety of olmesartan- ______containing products and will communicate again if additional information becomes available. To report a serious problem: Olmesartan medoxomil is an angiotensin II receptor 1-800-332-1088 (phone) blocker (ARB) approved for the treatment of high blood 1-800-FDA-0178 (fax) pressure, alone or with other antihypertensive agents, and ______is one of eight marketed ARB drugs.

Health care professionals should tell patients to contact MedWatch online: them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan- http://www.fda.gov/MedWatch/report.htm containing product, even if it takes months to years for ______symptoms to develop. Patients should contact their health care professional right away if they take an olmesartan- By mail (use postage-paid FDA Form 3500): containing product and experience severe diarrhea, MedWatch diarrhea that does not go away, or significant weight loss. 5600 Fishers Lane (7/3/13) Rockville, MD 20857

Miscellaneous

FUTURE DRUG RELEASES LISTED ON NEXT PAGE. Smokers and Depression: Chantix (varenicline) is indicated for use as an aid to smoking cessation treatment; it also can help smokers with depression to quit smoking. The drug manufacturer Pfizer sponsored a clinical trial to assess how varenicline can contribute to the smoking cessation process. The study also documented mood and anxiety levels in smokers with depression (or a history of depression disorders). The results are published in the Annals of Internal Medicine and show that this medication therapy can assist some patients to cease from smoking with no increase in depression or anxiety. (9/16/13)

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

Brand Manufactur- Estimated Generic Name Brand Name Indication(s) / Use Approval/ er Market Date Gastroesophageal reflux rabeprazole Aciphex Eisai approved† disease (GERD), ulcers nedocromil ophthalmic Alocril Allergan Allergies approved† rosiglitazone Avandia GlaxoSmithKline Type 2 diabetes approved† dexmethylphenidate extended-release cap- Focalin XR Novartis Attention-deficit/hyperactivity disorder approved† sule lidocaine Lidoderm Endo Pharmaceuticals Pain approved† sodium phosphate monobasic monohy- drate & sodium phos- Visicol Salix Pharmaceuticals Colon cleansing prior to colonoscopy approved† phate dibasic anhy- drous lovastatin/niacin Advicor Abbott Cholesterol SEP 2013 mycophenolate injec- CellCept Roche Palo Kidney, heart, or liver transplant SEP 2013 tion niacin ER tablet Niaspan Abbott Cholesterol SEP 2013 valganciclovir Valcyte Roche Cytomegalovirus SEP 2013 hydromorphone hy- Exalgo Mallinckrodt Moderate to severe pain NOV 2013 drochloride duloxetine hydrochlo- Anxiety, depression, fibromyalgia, neuropa- Cymbalta Lilly DEC 2013 ride thy fluocinonide Vanos Medicis Plaque-type psoriasis DEC 2013 estradiol Vivelle-Dot Novartis Symptoms of menopause DEC 2013 transdermal patch capecitabine Xeloda Roche Breast cancer, colorectal cancer DEC 2013 flunisolide Aerospan Acton Asthma 2013 mesalamine Asacol Warner Chilcott Ulcerative colitis, proctitis 2013 imiglucerase injection Cerezyme Genzyme Gaucher disease 2013 alendronate/ Fosamax Plus D Merck Osteoporosis 2013 cholecalciferol tolterodine ER Detrol LA Pfizer Overactive bladder JAN 2014 ethinyl estradiol/ Loestrin 24 Fe Warner Chilcott Birth control pill JAN 2014 norethindrone telmisartan Micardis Boehringer Ingelheim High blood pressure JAN 2014 telmisartan/ Micardis HCT Boehringer Ingelheim High blood pressure JAN 2014 hydrochlorothiazide sirolimus tablet Rapamune Wyeth Organ rejection prevention JAN 2014 fenofibric acid Trilipix Abbott Cholesterol JAN 2014 doxercalciferol Hectorol Sanofi-Aventis Hyperparathyroidism FEB 2014 moxifloxacin Avelox Bayer Antibiotic MAR 2014 raloxifene Evista Lilly Osteoporosis, breast cancer risk reduction MAR 2014 sirolimus oral solution Rapamune Wyeth Organ rejection prevention MAR 2014 sevelamer Renvela Genzyme Chronic kidney disease MAR 2014 carbonate tablet ezetimibe/simvastatin Vytorin Merck Cholesterol MAR 2014 prednisolone Orapred ODT Shionogi Pharma Asthma, atopic dermatitis, allergic rhinitis APR 2014 nelfinavir mesylate Viracept ViiV Healthcare Antiretroviral APR 2014 eszopiclone Lunesta Sepracor Insomnia MAY 2014 Gastroesophageal reflux esomeprazole Nexium AstraZeneca MAY 2014 disease (GERD), ulcers argatroban 100mg/mL Acova Pfizer Thrombosis JUN 2014 risedronate Actonel Procter & Gamble Osteoporosis JUN 2014 tazarotene Tazorac Gel Allergan Acne vulgaris, plaque psoriasis JUN 2014 mometasone furoate Nasonex Schering Allergies JUL 2014 bimatoprost Lumigan Allergan Glaucoma, ocular hypertension AUG 2014 adefovir dipivoxil Hepsera Gilead Chronic hepatitis B SEP 2014

sevelamer hydrochlo- Renagel Genzyme Chronic kidney disease SEP 2014 ride sevelamer carbonate Renvela Genzyme Chronic kidney disease SEP 2014 suspension amlodipine/valsartan Exforge Novartis High blood pressure OCT 2014 amlodipine/valsartan/ Exforge HCT Novartis High blood pressure OCT 2014 hydrochlorothiazide tobramycin Tobi Novartis Cystic fibrosis OCT 2014 travoprost Travatan Z Travatan Z Glaucoma, ocular hypertension DEC 2014 memantine tablet Namenda Forest Alzheimer’s disease JAN 2015 ritonavir Norvir Abbott Antiviral JAN 2015 trandolapril/ Tarka Abbott High blood pressure FEB 2015 verapamil efavirenz Sustiva Bristol-Myers Squibb Antiviral MAR 2015 colesevelam tablet Welchol Daiichi Sankyo Cholesterol MAR 2015 omega-3-acid Lovaza GlaxoSmithKline Cholesterol 1Q2015 ethyl esters aripiprazole Abilify Otsuka Psychiatric conditions APR 2015 Chemo-associated nausea & vomiting; pre- aprepitant Emend Merck APR 2015 vention of post-op nausea & vomiting oxybutynin Oxytrol Watson Overactive bladder APR 2015 linezolid tablet Zyvox Pfizer Bacterial infections MAY 2015 epinephrine Epipen Mylan Anaphylactic reactions JUN 2015 gemifloxacin tablet Factive Cornerstone Antibiotic JUN 2015 aspirin/dipyridamole Aggrenox Boehringer Ingelheim Stroke prevention JUL 2015 imatinib Gleevec Novartis Cancer JUL 2015 testosterone Androgel 1% Solvay Hormone replacement AUG 2015 glatiramer acetate Copaxone Teva Multiple sclerosis SEP 2015 guanfacine ER tablets Intuniv Actavis ADHD SEP 2015 fenofibrate Fenoglide Santarus Cholesterol OCT 2015 dutasteride Avodart GlaxoSmithKline Benign prostatic hyperplasia NOV 2015 almotriptan Axert Ortho-McNeil-Janssen Migraine NOV 2015 dutasteride/tamsulosin Jalyn GlaxoSmithKline Benign prostatic hypertrophy NOV 2015 celecoxib Celebrex Pfizer Osteoarthritis, pain DEC 2015 norgestimate/ Ortho Tri-Cyclen Lo Ortho Mcneil Janssen Birth control pill DEC 2015 ethinyl estradiol olopatadine Pataday Alcon Allergic conjunctivitis DEC 2015 olopatadine Patanol Alcon Allergic conjunctivitis DEC 2015 metformin hydrochlo- Glumetza Santarus Type 2 diabetes mellitus FEB 2016 ride ER abacavir/lamivudine Epzicom GlaxoSmithKline Antiviral MAR 2016 armodafinil Nuvigil Teva Sleep disorders JUN 2016 rosuvastatin Crestor AstraZeneca Cholesterol JUL 2016 darifenacin Enablex Novartis Overactive bladder AUG 2016 olmesartan Benicar Daiichi Sankyo High blood pressure OCT 2016 olmesartan/ hydro- Benicar HCT Daiichi Sankyo High blood pressure OCT 2016 chlorothiazide quetiapine ER tablet Seroquel XR AstraZeneca Antipsychotic NOV 2016 lopinavir/ritonavir Kaletra Abbott Antiviral DEC 2016 cinacalcet tablet Sensipar Amgen Hyperparathyroidism, hypercalcemia DEC 2016 ezetimibe Zetia Merck Cholesterol DEC 2016 atomoxetine Strattera Lilly Attention-deficit/hyperactivity disorder MAY 2017 atazanavir Reyataz Bristol-Myers Squibb Antiretroviral JUL 2017 caspofungin acetate Cancidas Merck Fungal infections SEP 2017 tadalafil Adcirca Synthon Pulmonary arterial hypertension NOV 2017 tenofovir Viread Gilead Antiviral JAN 2018 repaglinide Prandin Novo Nordisk Type 2 diabetes JUN 2018 fentanyl buccal tablet Fentora Cephalon Breakthrough cancer pain OCT 2018 vardenafil Levitra Teva Erectile dysfunction OCT 2018 Diabetic peripheral neuropathy, postherpetic pregabalin Lyrica Pfizer DEC 2018 neuralgia, seizure, fibromyalgia dolasetron Anzemet Sanofi Aventis Nausea/vomiting uncertain efavirenz/ emtricitabine/ Atripla Gilead Antiviral uncertain tenofovir metformin/ Avandamet GlaxoSmithKline Type 2 diabetes uncertain rosiglitazone

rosiglitazone/ Avandaryl GlaxoSmithKline Type 2 diabetes uncertain glimepiride valsartan Diovan Novartis High blood pressure uncertain rivastigmine solution Exelon Novartis Alzheimer’s disease/Parkinson’s disease uncertain fluvastatin ER tablet Lescol XL Novartis Cholesterol uncertain trazodone ER tablet Oleptro Angelini Depression uncertain 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 FDA Filing/ Drug Name Manufacturer Indication(s) / Use Approval/ Market Date Human Genome Abthrax (raxibacumab) Inhalation anthrax approved† Sciences Fycompa (perampanel) Eisai Adjunct therapy for partial onset seizures approved† Stendra (avanafil) Vivus A PDE5 inhibitor for erectile dysfunction approved† A synthetic surfactant for prevention of respiratory Surfaxin (lucinactant) Discovery Labs approved† distress syndrome in premature infants Valchlor Yaopon Early stage (stages I-IIA) mycosis fungoides approved† (mechlorethamine) JUN – NOV TBA (suvorexant) Merck Insomnia 2013 TBA (naloxegol) AstraZeneca, Nektar Opioid-induced constipation 3Q2013 4Q2013 (fil- TBA (daclatasvir) Bristol Myers Squibb Hepatitis C virus infection ing*) Pulmonary arterial hypertension, chronic Adempas (riociguat) Bayer OCT 2013 thromboembolic pulmonary hypertension Aprela (bazedoxifene/ Menopausal symptoms and prevention Ligand, Pfizer OCT 2013 conjugated estrogens of postmenopausal osteoporosis Brintellix (vortioxetine) Lundbeck, Takeda Major depressive disorder OCT 2013 Opsumit (macitentan) Actelion Pulmonary arterial hypertension OCT 2013 TBA (canagliflozin/ Janssen Type 2 diabetes OCT–DEC 2013 metformin IR) Oralair (grass pollen al- Stallergenes, Sublingual tablet formulation of a freeze dried extract of NOV 2013 lergen immunotherapy) Paladini grass pollen allergens for allergic rhinitis Forest, Schizophrenia; acute treatment of manic or mixed episodes associ- TBA (cariprazine) NOV 2013 Gedeon Richter ated with bipolar I disorder Used in combination with pegylated interferon & ribavirin for TBA (simeprevir) Medivir, Janssen NOV 2013 treatment of genotype 1 chronic hepatitis C in adult patients Grazax, Alutard SQ NOV 2013 – (ALK grass pollen tablet, Merck, ALK-Abello Prevention of allergies caused by grass pollen allergen JAN 2014 phleum pretense) NOV 2013 – Syncria (albiglutide) GlaxoSmithKline Type 2 diabetes JAN 2014 Lulicon, Lulifin Topica, Vanda Topical treatment of Tinea Pedis; onychomycosis DEC 2013 (luliconazole) Sanofi Aventis, Zea- Lyxumia (lixisenatide) Type 2 diabetes DEC 2013 land TBA (sofosbuvir) Gilead Hepatitis C virus infection DEC 2013 AstraZeneca, Forxiga (dapagliflozin) Type 2 diabetes 2013 Bristol Myers Squibb Girosa (filbanserin) Sprout Hypoactive sexual desire disorder in premenopausal women 2013 Impavido (miltefosine) Paladin Treatment of leishmaniasis 2013 Hyponatremia associated with heart failure & syndrome of inap- Lixar (lixivaptan) Cornerstone 2013 propriate antidiuretic hormone Luveniq (voclosporin) Lux Biosciences Uveitis 2013 Decrease birthing time to vaginal delivery for women who have an Misopress (misoprostol) Ferring 2013 unfavorable cervix Solpura (liprotamase) Eli Lilly Exocrine pancreatic insufficiency 2013 Stedesa (eslicarbazepine) Sunovion Adjunct therapy for partial-onset seizures 2013 4Q2013 (fil- TBA (eliglustat tartrate) Genzyme Gaucher disease type 1 ing*) Actimid (pomalidomide) Celgene Myelofibrosis 2013 (filing*) AL-60371 Alcon Otitis externa and media with a tympanostomy tube 2013 (filing*)

Elonva Merck Infertility 2013 (filing*) (corifollitropin alfa) Faridak (panobinostat) Novartis Multiple myeloma 2013 (filing*) Ideglira (insulin Novo Nordisk Type 2 diabetes 2013 (filing*) degludec/liraglutide) Kremezin (carbonaceous Mitsubishi Tanabe Chronic kidney disease 2013 (filing*) oral adsorbent) Lixiana (edoxaban) Daiichi Sankyo Stroke prevention in atrial fibrillation 2013 (filing*) Chelsea Therapeu- Northera (droxidopa) Neurogenic orthostatic hypotension 2013 (filing*) tics GW Pharmaceuticals Sativex (nabiximols) Cancer pain; spasticity in multiple sclerosis 2013 (filing*) Otsuka Solorel (macimorelin) Aeterna Zentaris Growth hormone deficiency, treatment of cachexia 2013 (filing*) TBA (bardoxolone me- Reata, Abbott Diabetic nephropathy; chronic kidney disease 2013 (filing*) thyl) TBA (dovitinib) Novartis Renal cell cancer 2013 (filing*) TBA (dulaglutide) Eli Lilly Type 2 diabetes 2013 (filing*) TBA (dutogliptin) Phenomix Type 2 diabetes 2013 (filing*) TBA (ecopipam) Psyadon Lesch Nyhan disease 2013 (filing*) TBA (edivoxetine) Eli Lilly Major depressive disorder; attention deficit hyperactivity disorder 2013 (filing*) Myeloproliferative disorders including polycythemia vera, TBA (fedratinib) Sanofi thrombocythemia, essential thrombocytosis, & myelofibrosis with 2013 (filing*) myeloid metaplasia TBA (linifanib) Abbott Hepatocellular carcinoma 2013 (filing*) TBA (rolapitant) OPKO, Tesaro Prevention of chemotherapy-induced nausea & vomiting 2013 (filing*) Newron, TBA (safinamide) Parkinson’s disease 2013 (filing*) Merck Serono TBA (secukinumab) Novartis Moderate to severe plaque psoriasis 2013 (filing*) Vanda, TBA (tasimelteon) Insomnia, sleep disorders, depression 2013 (filing*) Bristol Myers Squibb TBA (taspoglutide) Ispen Type 2 diabetes 2013 (filing*) TBA (tavaborole) Anacor Oncyhomycosis 2013 (filing*) SIGA Technologies, TBA (tecovirimat) Smallpox infection 2013 (filing*) ViroPharma TBA (tedizolid phos- Trius Acute bacterial skin & skin structure infections 2013 (filing*) phate) TBA (umeclidinium) GlaxoSmithKline Chronic obstructive pulmonary disease, asthma 2013 (filing*) Accidental overexposure to fluorouracil (5-FU) due to dosing errors TBA (uridine triacetate) BTG, Wellstat 2013 (filing*) or impaired clearance of 5-FU from the body GlaxoSmithKline, TBA (vilanterol) Chronic obstructive pulmonary disease 2013 (filing*) theravance TBA (vorapaxar sulfate) Merck Cardiovascular event prevention in select patients 2013 (filing*) Vivageln/A Starpharma Bacterial vaginosis 2013 (filing*) Acute bacterial skin & skin structure infections caused by gram- Zeven (dalbavancin) Durata Therapeutics positive bacteria including MRSA (methicillin resistant Staphylo- 2013 (filing*) coccus aureus) Zydena (udenafil) Warner Chilcott Erectile dysfunction 2013 (filing*) 2013 – 2014 TBA (avatrombopag) Eisai Immune thrombocytopenic purpura (filing*) TBA 2013 – 2014 Eisai Endometrial cancer, thyroid cancer (lenvatinib mesylate) (filing*) 2013 – 2014 TBA (orteronel) Takeda Metastatic castrate-resistant prostate cancer (filing*) TBA (palonosetron/ 2013 – 2014 Helsinn, Eisai Chemotherapy-induced nausea & vomiting netupitant) (filing*) TBA (apremilast) Celgene Psoriatic arthritis MAR 2014 TBA (vedolizumab) Millenium, Takeda Moderate to severely active Crohn’s disease, and ulcerative colitis JUN 2014 Esbriet (pirfenidone) InterMune Idiopathic pulmonary fibrosis 2014 TBA (asfotase alfa) Alexion Hypophosphotasia 1Q2014 (filing*) Boehringer TBA (empagliflozin) Type 2 diabetes 1Q2014 (filing*) Ingelheim, Eli Lilly 4Q2014 (fil- TBA (lasmiditan) CoLucid Treatment of migraine ing*) Arimenda Adamas, Forest Alzheimer’s dementia 2014 (filing*) (memantine/donepezil) Cinquil (reslizumab) UCB Eosinophilic asthma 2014 (filing*) FV-100 Inhibitex Varicella zoster virus infection, herpes zoster 2014 (filing*) Lupuzor (forigerimod) ImmuPharma Systemic Lupus erythematosus 2014 (filing*) 16

Mitizax (allergy immuno- Rhinitis & asthma allergy symptoms caused by house Merck, ALK-Abello 2014 (filing*) therapy tablet) dust mite allergen MuDelta: JNJ-27018966 Furiex Diarrhea-predominant irritable bowel syndrome 2014 (filing*) Prevention & treatment of muscle wasting in patients with ad- Ostarine (enobosam) GTx 2014 (filing*) vanced non-small cell lung cancer TBA Novartis Heart failure 2014 (filing*) (AHU-377/valsartan) Regeneron, Sanofi TBA (alirocumab) Cholesterol 2014 (filing*) Aventis Helsinn Therapeu- TBA (anamorelin) Treatment of cachexia & anorexia in cancer patients 2014 (filing*) tics TBA (auriclosene) NovaBay Adenoviral conjunctivitis 2014 (filing*) TBA (brexpiprazole) Otsuka, Lundbeck Schizophrenia, adjunctive therapy for major depressive disorder 2014 (filing*) TBA (cobimetinib) Genentech In combination with Zelboraf for metastatic melanoma 2014 (filing*) TBA (eluxadoline Furiex Diarrhea-predominant irritable bowel syndrome 2014 (filing*) dihydrochloride) TBA (erismodegib) Novartis Solid tumors 2014 (filing*) Boehringer TBA (faldaprevir) Hepatitis C virus infection 2014 (filling*) Ingelheim TBA (lebrikizumab) Genentech Asthma 2014 (filing*) Ardea Biosciences, TBA (lesinurad) Hyperuricemia, gout 2014 (filing*) AstraZeneca TBA Vertex Cystic fibrosis homozygous for F508del CFTR mutation 2014 (filing*) (lumacaftor/ivacaftor) TBA (mavoglurant) Novartis Fragile X syndrome 2014 (filing*) Amicus Therapeu- TBA (migalastat) tics, Glax- Fabry disease 2014 (filing*) oSmithKline Acute uncomplicated influenza as monotherapy or in combination TBA (nitazoxanide) Romark 2014 (filing*) with oseltamivir TBA (obeticholic acid) Intercept Primary biliary cirrhosis, hepatic fibrosis 2014 (filing*) TBA (odanacatib) Merck, Celera Osteoporosis 2014 (filing*) TBA (omarigliptin) Merck Type 2 diabetes 2014 (filing*) TBA (patiromer) Relypsa Hyperkalemia in patients with chronic kidney disease 2014 (filing*) TBA (pimavanserin) Acadia, Biovail Parkinson’s disease psychosis 2014 (filing*) TBA (pradigastat) Novartis Familial chylomicronemia syndrome 2014 (filing*) TBA (preladenant) Merck Parkinson’s disease 2014 (filing*) Dainippon Sumito- TBA (ranirestat) Diabetic peripheral neuropathy 2014 (filing*) mo Pharma, Eisai Sanofi Aventis, TBA (sarilumab) Rheumatoid arthritis, ankylosing spondylitis 2014 (filing*) Regeneron TBA (tildrakizumab) Merck Psoriasis 2014 (filing*) FSH-GEX, 2014 -2015 (fil- Glycotype Infertility GT-GP 2.4 GEX ing*) Eleison, Threshold 2014 -2015 (fil- TBA (glufosfamide) Pancreatic cancer Pharmaceuticals ing*) Visonac 2014 -2015 (fil- Photocure Topical treatment for acne (methyl aminoevulinate) ing*) Firdapse (amifampridine Catalyst Lambert-Eaton myasthenic syndrome 2015 (filing*) phosphate) Isis-ApoIIIRx, Isis Hypertriglyceridemia 2015 (filing*) Isis-304801 Rydapt (midostaurin) Novartis Acute myeloid leukemia, aggressive systemic mastocytosis 2015 (filing*) Stedicor (azimilide) Forest Ventricular arrhythmia 2015 (filing*) Cardiovascular disease risk reduction in TBA (aleglitazar) Takeda 2015 (filing*) high-risk patients with type 2 diabetes TBA (bevenopran) Eli Lilly Opioid-induced constipation 2015 (filing*) TBA (bitopertin) Roche Schizophrenia 2015 (filing*) TBA (brodalumab) Amgen, AstraZeneca Moderate to severe plaque psoriasis 2015 (filing*) TBA (buparlisib) Novartis Breast cancer 2015 (filing*) TBA (ozenoxacin) Ferrer Skin & skin structure infections 2015 (filing*) TBA (surotomycin) Cubist Clostridium difficile-associated diarrhea 2015 (filing*) Bone loss disorders, including postmenopausal 2015-2016 (fil- TBA (romosozumab) UCB, Amgen osteoporosis and bone fractures ing*) TBA (alisporivir) Novartis Hepatitis C virus infection 2016 (filing*) TBA (elagolix) Abbott, Neurocrine Endometriosis 2016 (filing*)

Beriplex (human 4-factor Urgent reversal of vitamin K-antagonist (warfarin) therapy prothrombin complex CSL, Behring uncertain in patients with acute major bleeding concentrate) Linjeta (insulin, human) Biodel Type 1 or Type 2 diabetes uncertain Pandemrix, Prepandrix H5N1 avian influenza for pre-pandemic use (Prepandrix) GlaxoSmithKline uncertain (H5N1 influenza vaccine) & pandemic use (Pandemrix) Striverdi Respimat Boehringer Asthma, chronic obstructive pulmonary disease uncertain (olodaterol) Ingelheim TBA (cobicistat) Gilead HIV-1 infection uncertain TBA (efinaconazole) Kaken, Valeant Distal lateral subungal onychomycosis uncertain TBA (elvitegravir) Gilead HIV-1 infection in treatment-experienced adults uncertain Diabetes and/or hypertriglyceridemia in those with TBA (metreleptin) Amylin uncertain rare forms of lipodystrophy Vyndaqel FoldRx, Pfizer Transthyretin familial amyloid polyneuropathy uncertain (tafamidis meglumine) 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 FDA Filing/ Drug Name Manufacturer Indication(s) / Use Approval/ Market Date Adasuve (loxapine) Alexza, Valeant Rapid treatment of agitation in schizophrenia & bipolar disorder approved† Cornerstone Thera- Bethkis (tobramycin) Cystic fibrosis patients with Pseudomonas aeruginosa approved† peutics Flublok Protein Sciences Influenza prevention in adults 18 years of age and older approved† (influenza vaccine) Sitavig (acyclovir lauriad) BioAlliance Herpes simplex virus-1 infections approved† Ximino (minocycline Ranbaxy Moderate to severe acne approved† extended-release) Flu Q-QIV; D-QIV AUG – OCT (quadrivalent inactivated Biologicals Influenza prevention in those >/= 3 years of age 2013 split virion vaccine) Neugranin (balugrastim) Teva Chemotherapy-induced neutropenia 4Q2013 TBA (diclofenac Iroko Mild to moderate acute pain in adults 4Q2013 nano-formulation) Zecuity (sumatriptan NuPathe Migraine 4Q2013 transdermal) Afrezza (insulin human [rDNA origin] inhalation MannKind Type 1 & Type 2 diabetes SEP 2013 powder) Duodopa SEP – OCT Abbott Parkinson’s disease (carbidopa/levodopa) 2013 Actemra (tocilizumab) Roche Rheumatoid arthritis OCT 2013 Iluvien (fluocinolone acetonide extended- Alimera, pSivida Diabetic macular edema OCT 2013 release) Rheumatoid arthritis, poly-articular-course juvenile rheumatoid Otrexup (methotrexate) Antares OCT 2013 arthritis, psoriasis TBA Neos Therapeutics Attention deficit hyperactivity disorder OCT 2013 (amphetamine polistirex) Anoro Ellipta GlaxoSmithKline, (umeclidinium bromide/ Chronic obstructive pulmonary disease DEC 2013 Theravance vilanterol) TBA Actavis New external form for prevention of pregnancy DEC 2013 (norethindrone acetate) adenovirus types 4 & 7 Teva Prevention of severe acute respiratory diseases 2013 (live oral vaccines) Clearazide Yaupon Therapeu- Early stage (stages I-IIA) mycosis fungoides 2013 (mechlorethamine) tics, Ceptaris Contrave (naltrexone/ bupropion extended- Orexigen, Takeda Obesity 2013 release) Fetzima Forest Major depressive disorder 2013 (levomilnacipran) Milprosa (progesterone) Teva Luteal phase support for women undergoing in-vitro fertilization 2013

MoxDuo IR (mor- QRxPharma, Actavis New oral formulation for moderate to severe acute pain 2013 phine/oxycodone) Remoxy (oxycodone con- Pfizer, Pain Thera- Moderate to severe chronic pain 2013 trolled-release) peutics Durect Rytary (carbidopa/ levo- Impax Parkinson’s disease 2013 dopa extended-release) TBA (tacrolimus extend- Prophylaxis of organ rejection in adult kidney transplant recipients Astellas 2013 ed-release) & adult male liver transplant recipients TBA (zucapsaicin/ Winston Osteoarthritis 2013 ciscapsaicin) Treatment of keratoconus & corneal ectasia Vibex (riboflavin) Avedro 2013 following refractive surgery Zoely (nomegesterol ace- Merck Prevention of pregnancy 2013 tate/17 beta-estradiol) Zohydro (hydrocodone bitartrate extended- Zogenix, Elan Moderate to severe chronic pain 2013 release) 3Q2013 (fil- TBA (budesonide) Salix Ulcerative colitis ing*) 3Q2013 (fil- TBA (sufentanil nanotab) AcelRx Post-operative pain ing*) Lightlake Therapeu- 3Q2013 – 2014 TBA (naloxone) Binge eating disorder tics (filing*) Ventrus, SLA 4Q2013 (fil- Anoheal (diltiazem) Pain associated with anal fissure Pharma ing*) 4Q2013 (fil- TBA (ondansetron) RedHill BioPharma Prevention of nausea & vomiting in cancer patients ing*) TBA 4Q2013 (fil- (perindopril arginine/ Symplmed, XOMA Hypertension ing*) amlodipine besylate) Ameluz (5-aminolevulinic acid Biofrontera Actinic keratosis 2013 (filing*) nanocolloidal) Bromsite (bromfenac) InSite Vision Pain, swelling, & inflammation associated with ocular surgery 2013 (filing*) CompleoTRT (testos- Trimel Male hypogonadism 2013 (filing*) terone intranasal) Dexasite (dexame- InSite Vision Blepharitis 2013 (filing*) thasone) Duromist (sildenafil) NovaDel Erectile dysfunction 2013 (filing*) Watson, Gedeon Esmya (ulipristal acetate) Anemia associated with uterine leiomyomas 2013 (filing*) Richter Kalbitor (ecallantide) Dyax Concentrated formulation for hereditary angioedema 2013 (filing*) Lecette (desogestrel/ Teva Prevention of pregnancy 2013 (filing*) ethinyl estradiol) Mycova (terbinafine) ApriCus Onychomycosis 2013 (filing*) Natpara (recombinant human NPS, Takeda Hypoparathyroidism 2013 (filing*) parathyroid hormone) Octreolin Chiasma, Roche Acromegaly 2013 (filing*) (ocreotide acetate) Posidur (bupivacaine SR) Durect, Hospira Postoperative pain 2013 (filing*) Relistor (methylnaltrexone bro- Salix Opioid-induced constipation in chronic pain 2013 (filing*) mide) TBA (dapagliflozin/ AstraZeneca, Bristol Type 2 diabetes 2013 (filing*) metformin) Myers Squibb TBA (dexamethasone) EyeGate Dry eye, uveitis 2013 (filing*) TBA (dexamethasone) Icon Bioscience Treatment of inflammation associated with cataract surgery 2013 (filing*) TBA KemPharm, Mono- Attention deficit hyperactivity disorder 2013 (filing*) (dextroamphetamine) Sol Rx TBA (ethinyl estradi- Agile Therapeutics Prevention of pregnancy 2013 (filing*) ol/levonorgestrel) TBA (etodolac/lidocaine) IL Pharma, Kowa Pain & inflammation 2013 (filing*) TBA (ferric iron complex) Shield Therapeutics Iron deficiency anemia associated with inflammatory bowel disease 2013 (filing*) TBA (ferric trimaltol) Vitra Iron deficiency anemia associated with inflammatory bowel disease 2013 (filing*) Eli Lilly, Boehringer TBA (insulin glargine) Type 1 & 2 diabetes 2013 (filing*) Ingelheim

TBA (ketoprofen/ Irrigation solution formulation for the treatment of pain & im- amitriptyline/ Omeros 2013 (filing*) provement of joint function associated with arthroscopy oxymetazoline) TBA Shionogi, Sciele Premature ejaculation 2013 (filing*) (lidocaine/prilocaine) TBA (oxycodone) Phosphagenics Moderate to severe pain 2013 (filing*) TBA Santarus Infectious diarrhea 2013 (filing*) (rifamycin SV MMX) Improved tablet formulation for kidney transplant rejection pre- TBA (tacrolimus) Veloxis 2013 (filing*) vention Tredaptive (niacin extended-release/ Merck Cholesterol 2013 (filing*) laropiprant) Zerenex (ferric citrate) Keryx, Panacor Hyperphosphatemia in end-stage renal disease 2013 (filing*) Copaxone Teva Relapsing remitting multiple sclerosis JAN 2014 (glatiramer acetate) Prophylaxis of invasive Aspergillus & Candida infections in those Noxafil (posaconazole) Merck FEB 2014 who are severely immunocompromised Plegridy (peginterferon Biogen Idec Relapsing remitting multiple sclerosis MAY 2014 beta-1a) Seebri Breezhaler (glycopyrronium bromide Vectura, Novartis Chronic obstructive pulmonary disease 1Q2014 (filing*) long-acting) TBA (aclidinium bro- Forest, Almirall Chronic obstructive pulmonary disease 1Q2014 (filing*) mide/formoterol) TBA Forest Hypertension 1Q2014 (filing*) (nebivolol/valsartan) TBA (omeprazole imme- Secondary prevention of cardio- and cerebro-vascular events, re- JAN 2014 (fil- diate-release/ Pozen duce the risk of gastric ulcers in patients at risk of aspirin induced ing*) aspirin delayed-release) gastric ulcers Neuropathic pain associated with chemotherapy-induced peripher- Amiket (keta- EpiCept al neuropathy in patients previously treated with taxane-based 2014 (filing*) mine/amitriptyline) chemotherapy Androxal Repros Secondary hypogonadism 2014 (filing*) (enclomiphene citrate) Gram-negative lung infections caused by pseudomonas aeruginosa Arikace Insmed, Transave in patients with cystic fibrosis & bronchiectasis, non-tuberculous 2014 (filing*) (amikacin liposomal) mycobacteria lung infections Bema LA BioDelivery, Endo Moderate to severe chronic pain 2014 (filing*) (buprenorphine buccal) Impracor (ketoprofen) Imprimis Acute pain 2014 (filing*) TBA Eli Lilly, Boehringer Type 1 and Type 2 diabetes 2014 (filing*) (basal insulin analog) Ingelheim TBA (carvedilol CR) RedHill Biopharma Hypertension, heart failure 2014 (filing*) TBA (daclizumab) Biogen Idec, AbbVie Relapsing remitting multiple sclerosis 2014 (filing*) TBA (glycopyrronium Novartis Moderate/severe chronic obstructive pulmonary disease 2014 (filing*) bromide/indacaterol) Eli Lilly, Boehringer TBA (insulin peglispro) Type 1 and Type 2 diabetes 2014 (filing*) Ingelheim TBA (olopatadine) Alcon, Novartis Ocular allergy 2014 (filing*) TBA (pediatric hexavalent Merck Hepatitis B virus infection 2014 (filing*) combination vaccine) RedHill BioPharma, TBA (rizatriptan) Acute migraine 2014 (filing*) IntelGenX TBA Merck Type 2 diabetes, atherosclerosis 2014 (filing*) (sitagliptin/atorvastatin) TBA Gilead Hepatitis C virus infection 2014 (filing*) (sofosbuvir/ledipasvir) TBA (sumatriptan in- OptiNose, Avanir Acute treatment of migraine 2014 (filing*) tranasal) Toctino (alitretinoin) Basilea, Stiefel Atopic dermatitis (eczema) 2014 (filing*) Vycavert (hydrocodone/ Acura Moderate to severe pain 2014 (filing*) acetaminophen) Phenylase (phenylalanine BioMarin Phenylketonuria 2015 (filing*) hydroxylase) Secondary hyperparathyroidism associated with vitamin D insuffi- Replidea (calcifediol) Cytochroma 2015 (filing*) ciency in patients with chronic kidney disease

TBA (exenatide sus- Intarcia Therapeu- Type 2 diabetes 2015 (filing*) tained-release) tics TBA (glycopyrronium Pearl Therapeutics, bromide/ Chronic obstructive pulmonary disorder 2015 (filing*) AstraZeneca formoterol fumarate) TBA Taiho Pharmaceuti- Metastatic colorectal cancer 2015 (filing*) (trifluridine/tipiracil) cal Ryzodeg (insulin Novo Nordisk Type 1 & Type 2 diabetes 2016 degludec/insulin aspart) Tresiba Novo Nordisk Type 1 & Type 2 diabetes 2016 (insulin degludec) Alprox-TD, Vitaros Warner Chilcott Erectile dysfunction uncertain (alprostadil) Asacard Flamel, NewHaven Secondary prevention of cardiovascular disease uncertain (acetylsalicylic acid) Aveed (testosterone Endo Male hypogonadism uncertain undecanoate) Bronchitol (mannitol) Pharmaxis Cystic fibrosis uncertain Civanex Winston Osteoarthritis of the knee uncertain (civamide/zucapsaicin) Dyloject Javelin, Hospira Management of acute moderate to severe pain in adults uncertain (cyclodextrin/diclofenac) Epanova (eicosapentaenoic acid/ Omthera High triglycerides uncertain docosahexaenoic acid) Heplisav (hepatitis B Prevention of hepatitis B virus infection in healthy Dynavax uncertain virus vaccine) adults 18-70 years of age Levadex Map, Nektar, Aller- Migraine uncertain (dihydroergotamine) gan Optaflu Novartis Influenza virus infection prevention in patients >/= 18 years of age uncertain (influenza virus vaccine) Ostora (calcitonin/ re- Tarsa Therapeutics, Osteoporosis uncertain combinant salmon) Unigene Pennsaid (diclofenac Nuvo Research, Osteoarthritis of the knees uncertain sodium viscous solution) Mallinckrodt Probuphine (buprenor- Titan Opioid dependence in adults uncertain phine SR) Sefelsa (gabapentin CR) Depomed, Abbott Moderate to severe vasomotor symptoms due to menopause uncertain TBA (carbinoxamine) Tris Allergies uncertain TBA (cysteamine delayed-release/ Raptor Nephropathic cystinosis uncertain mercaptamine delayed- release) TBA (granisetron sus- AP Pharma Chemotherapy-induced nausea & vomiting uncertain tained-release) Twirla (ethinyl estradi- Agile Therapeutics Prevention of pregnancy uncertain ol/levonorgestrel)

References:

1. Pharmacist’s Letter, New Drugs Approved† by the FDA in 2012, Therapeutic Research Center, 1995-2012, last accessed 12/6/12, http://pharmacistsletter.therapeuticresearch.com/pl/NewDrugs.aspx?cs=&s=PL&pt=20 2. Pharmacist’s Letter, Anticipated Availability of First-Time Generics, Therapeutic Research Center, 3120 W. March Lane, PO Box 8190, Stockton, CA 95208, Copyright © 1995-2012, All rights reserved, last accessed 12/6/12, http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?nidchk=1&cs=&s=PL&dd=251011&pb=&pt=2&fpt=55&m enu=ftg 3. HealthTrans,Generic Pipeline Report, SXC company, 2012, last accessed 11/6/12, http://www.healthtrans.com/Clinical/Clinical_v2/Clinical%20Documents/2012-01-Drug%20Pipeline%20Report.pdf 4. Rx Outlook: Generic Pipeline 2012-2014, SXC Drug Information Services, 2012 SXC Health Solutions, Inc. Volume 6, Issue 1, 1st Quarter 2012 5. Rx Outlook: Generic Pipeline October 2012-2015, SXC Drug Information Services, 2012 SXC Health Solutions, Inc. Volume 6, Issue 4, 4st Quarter 2012 6. Rx Outlook: Non-specialty pipeline – remainder of 2012-2014, SXC Drug Information Services, 2012 SXC Health Solutions, Inc. Volume 6, Issue 5, 4st Quarter 2012 7. Rx Outlook: Non-specialty pipeline – 2013-2016, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Is- sue 5, 2nd Quarter 2013 8. Rx Outlook: Non-specialty pipeline – 2013-2016, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Is- sue 9, 3rd Quarter 2013

9. Rx Outlook: Specialty pipeline – 2013-2016, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 10, 3rd Quarter 2013 10. Rx Outlook: Generic Pipeline April 2013 to April 2016, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 4, 2nd Quarter 2013 11. Rx Outlook: Generic Pipeline July 2013 to July 2016, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 8, 3rd Quarter 2013 12. RxHighlights, SXC Health Solutions, Inc. Volume 5, Issue 7, 8 and 9, August 2012 13. RxHighlights, SXC Health Solutions, Inc. Volume 5, Issue 10, September 2012 14. RxHighlights, Catamaran, Volume 5, Issue 11, October 2012 15. Express Scripts, Medco, Estimated Dates of Possible First-time Generics/Rx-to-OTC Market Entry, June 2012