January through March 2014

that describe these risks. The revised label includes a new Updated Warnings—Current Drugs warning about this unapproved use. Doribax is not ap- proved to treat any type of pneumonia.

In the clinical trial that was stopped early, patients with Xarelto Warning Expanded: The boxed warning for ventilator-associated bacterial pneumonia received either Xarelto now includes the following statement regarding 7-day Doribax treatment or 10-day treatment with factors that can increase the risk of epidural or spinal he- imipenem and cilastatin. In the intent-to-treat population, matomas: “optimal timing between the administration of the 28-day all-cause mortality was higher in the Doribax Xarelto and neuraxial procedures is not known.” Before, arm (23.0%; n=31/135) than in the imipenem and the boxed warning stated “factors that can increase the risk cilastatin arm (16.7%; n=22/132). Clinical cure rates were of epidural or spinal hematomas in patients being treated also lower in the Doribax arm. with Xarelto include use of indwelling epidural catheters; Health care professionals should consider whether the concomitant use of other drugs that affect hemostasis, such benefits of Doribax treatment are likely to exceed its poten- as nonsteroidal anti-inflammatory drugs (NSAIDs), plate- tial risks in patients who develop pneumonia while on ven- let inhibitors, or other anticoagulants; a history of traumat- tilators. Doribax is still considered safe and effective for its ic or repeated epidural or spinal punctures; or a history of FDA-approved indications - treatment of adults with com- spinal deformity or spinal surgery”. This is cur- plicated intra-abdominal infections and complicated uri- rently approved by the FDA in patients with nonvalvular nary tract infections, including kidney infections (pyelone- atrial fibrillation for the reduction of risk of stroke and em- phritis). (3/6/14) bolism. Xarelto is also approved to treat deep vein throm- bosis (DVT), pulmonary embolism (PE), and as prophylax- N-acetyl-leucine Found in Samples of Recalled is in DVT which may lead to PE in patients undergoing Product: The FDA has tested samples from recalled lots knee or hip replacement. (3/11/14) of Medisca’s L-citrulline product, and has found that the

samples contain N-acetyl-leucine, which is used to treat a Nizoral Tablets—Boxed Warning Expanded: The certain type of dizziness (acute vestibular vertigo). No L- boxed warning for Nizoral tablets, generic name ketocona- citrulline was found in the samples FDA tested. zole, has been expanded by the FDA. Before, the boxed The samples were analyzed by several laboratory methods warning listed that Nizoral tablets were contraindicated to identify the ingredient present in the product that was with cisapride, dofetilide, quinidine, and pimozide. The repackaged by Medisca and labeled as L-citrulline. boxed warning has now been revised to state that ketocon- These results reinforce the FDA’s concern about Medisca’s azole is contraindicated when co-administered with product labeled as L-citrulline and serve to remind patients dofetilide, quinidine, pimozide, cisapride, methadone, and clinics not to use any recalled Medisca L-citrulline disopyramide, dronedarone, and ranolazine. This medica- product with lot numbers 95482/A, 95482/B, 95482/C, tion is approved to treat patients with blastomycosis, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D. coccidioidomycosis, histoplasmosis, chromomycosis, or FDA is updating its recommendation to health care profes- paracoccidioidomycosis who have not responded or are sionals so that they can focus their attention on following intolerant to other therapies. (3/7/14) up with the patients who are believed to be at greatest risk Doribax—Safety Risk When Used to Treat of receiving a mislabeled product. Pneumonia: The FDA has concluded that Doribax FDA will continue to provide additional information as it (doripenem), an antibacterial drug used to treat patients becomes available. (2/18/14) who develop pneumonia while on ventilators, carries an Cozaar—New Boxed Warning: A new boxed warning increased risk of death and lower clinical cure rates com- for Cozaar, generic name losartan, has been issued by the pared to use of imipenem and cilastatin for injection (mar- FDA. The boxed warning states that this drug should be keted in the U.S. under the name Primaxin). Based on a discontinued in women as soon as possible when pregnan- FDA analysis of data from a three-year clinical trial that cy is detected. The reasoning behind the boxed warning is was prematurely stopped in 2011 due to these safety con- that that directly act on the renin-angiotensin cerns, FDA approved changes to the Doribax drug label www.AmericanHealthCare.com

For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 1 system may cause injury or death to a developing fetus. benefits of testosterone treatment are likely to exceed the Cozaar is currently approved by the FDA to treat hyperten- potential risks of treatment. The prescribing information in sion and to reduce the risk of stroke in patients who have the drug labels of FDA-approved testosterone products hypertension and ventricular hypertrophy. Cozaar is also should be followed. (1/31/14) indicated for the treatment of diabetic neuropathy in pa- tients who have an elevated serum creatinine and Undeclared Drug Ingredients Found in Pro proteinurea with type 2 diabetes and a history of hyperten- ArthMax: The FDA is advising consumers not to sion. (2/13/14) purchase or use Pro ArthMax, a product promoted and sold as a dietary supplement for joint, muscle and arthritic pain. Saxagliptin—Risk of Heart Failure: The FDA has re- Pro ArthMax is labeled in English, but also promoted to the quested clinical trial data from the manufacturer of Korean-speaking community as “프로알쓰맥스 .” saxagliptin to investigate a possible association between Consumers should stop using this product immediately and use of the type 2 diabetes drug and heart failure. FDA’s re- throw it away. quest resulted from a study published in the New England Human Science Foundation is voluntarily recalling all lots Journal of Medicine (NEJM), which reported an increased of Pro ArthMax 120 count bottle, labeled and sold as a rate of hospitalization for heart failure, when the heart does dietary supplement, to the consumer level. The product has not pump blood well enough, with use of saxagliptin (mar- been found to contain undeclared active pharmaceutical keted as Onglyza and Kombiglyze XR) compared to an in- ingredients (APIs), making it an unapproved new drug. active treatment. The study did not find increased rates of FDA sample analysis tested the product to contain the death or other major cardiovascular risks, including heart following APIs: 2.4mg of Chlorzoxazone, 0.78mg of attack or stroke, in patients who received saxagliptin. The Nefopam, 2.5mg of Diclofenac, 7.7mg of Ibuprofen, 2.1mg manufacturer is expected to submit the trial data to FDA by of Naproxen, and 1.9mg of Indomethacin. early March 2014, after which FDA will conduct a thorough Use of this product, containing the undeclared drug analysis and report findings publicly. ingredients listed above, has a reasonable probability of At this time, FDA considers information from the NEJM resulting in fatal adverse events in consumers and patients study to be preliminary. Analysis of the saxagliptin clinical with underlying illnesses, including known allergy to the trial data is part of a broader evaluation of all type 2 diabe- hidden ingredients, cardiac, gastrointestinal, hepatic, and tes drug therapies and cardiovascular risk. renal conditions as well as patients who have recently Saxagliptin is used along with diet and exercise to lower undergone cardiac bypass graft surgery. Consumers would blood sugar in adults with type 2 diabetes. It works by in- be unaware that the product contains NSAIDs (and other creasing the amount of produced by the body after ingredients), may inadvertently overdose by taking another meals, when blood sugar is high. NSAID concurrently, thus increasing the risk for NSAID Patients should not stop taking saxagliptin and should associated adverse events, which include but are not speak with their health care professionals about any ques- limited to, myocardial infarction, stroke, congestive heart tions or concerns. Health care professionals should contin- failure, renal toxicity, and bleeding, ulceration, or ue to follow the prescribing recommendations in the drug perforation of the stomach or intestines. labels. (2/11/14) Pro ArthMax is marketed as a dietary supplement for joint Testosterone Products—Risk of Cardiovascular pain and arthritis and is packaged in 120-count tablets per Events: The FDA is investigating the risk of stroke, heart bottle, in a white plastic screw top bottle. Product was attack, and death in men taking FDA-approved distributed to direct consignees in the state of California testosterone products. The FDA has been monitoring this then further distributed nationwide to retail stores and via risk and decided to reassess this safety issue based on the internet sales. recent publication of two separate studies that each Consumers should contact their physician or healthcare suggested an increased risk of cardiovascular events among provider if they have experienced any problems that may groups of men prescribed testosterone therapy. FDA is be related to taking or using this drug product. providing this alert while it continues to evaluate the Consumers/distributors/retailers that have product which information from these studies and other available data. is being recalled should stop using and return to place of FDA will communicate final conclusions and purchase. recommendations when the evaluation is complete. Human Science Foundation is notifying its distributors and Testosterone is a hormone essential to the development of customers by telephone and e-mail and is arranging for male growth and masculine characteristics. Testosterone return for credit of all recalled products. Consumers with products are FDA-approved only for use in men who lack questions regarding this recall can contact Human Science or have low testosterone levels in conjunction with an Foundation by email to [email protected] from associated medical condition. Monday through Friday, 10 AM and 4 PM, PST. (1/15/14) At this time, FDA has not concluded that testosterone Sodium Phosphate OTC Products Safety Risk: The treatment increases the risk of stroke, heart attack, or FDA is warning that using more than one dose in 24 hours death. Patients should not stop taking prescribed of over-the-counter (OTC) sodium phosphate drugs to treat testosterone products without first discussing any constipation can cause rare but serious harm to the kidneys questions or concerns with their health care professionals. and heart, and even death. Health care professionals should consider whether the

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 FDA has become aware of reports of severe dehydration to the Abbott recommended actions at and changes in the levels of serum electrolytes from taking https://www.abbottdiabetescare.com/press- more than the recommended dose of OTC sodium room/2014/2014-b.html. phosphate products, resulting in serious adverse effects on (3/16/14) organs, such as the kidneys and heart, and in some cases resulting in death. These serum electrolytes include Reumofan Plus: Pain Free by Nature is recalling calcium, sodium, and phosphate. According to the reports, "Reumofan Plus" Tablets purchased through their website most cases of serious harm occurred with a single dose of at www.painfreebynature.com, after the FDA discovered sodium phosphate that was larger than recommended or that the product was distributed in packaging that did not with more than one dose in a day. reveal the presence of the active pharmaceutical OTC sodium phosphate drug products include oral ingredients methocarbamol and diclofenac, making it an solutions taken by mouth and enemas used rectally. These unapproved drug. Use of this product could result in products are marketed under the brand-name Fleet, and as serious and life-threatening injuries. Distribution has been store brands and generic products. The medications are completely terminated by the company. also available as single-ingredient drug products, Reumofan Plus is used as a treatment for muscle pain, containing either sodium biphosphate or sodium arthritis, osteoporosis, bone cancer, and other conditions. phosphate, and as combination drug products containing This product comes in thirty (30) tablet containers and is both ingredients. packaged in a green and gold box. Consumers who are Consumers and health care professionals should always taking these products or who have recently stopped taking read the Drug Facts label for OTC sodium phosphate drugs Reumofan Plus should immediately consult a health care and use these products as recommended on the label, and professional. (3/14/14) not exceed the labeled dose. Caregivers should not give the oral products to children 5 years and younger without first VPRIV—Visible Particulate Matter Found: Shire discussing with a health care professional. Health care Pharmaceuticals announced a voluntary recall in the professionals should use caution when recommending an United States of one batch, packaged into three lots, of oral dose of these products for children 5 years and VPRIV due to the presence of visible particulate matter, younger. The rectal form of these products should never be identified as stainless steel and barium sulfate. The given to children younger than 2 years. (1/8/14) particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter root cause as the third Recalls/Suspensions party supplier fill finish process.

Any adverse events that may be related to the use of these products should be If infused, there is a possibility of rare but serious adverse reported to the FDA's MedWatch Adverse Event Reporting Program (contact information located at the end of the bulletin). events associated with particulate containing barium sulfate. The following packaged lots were recalled: FEW13-001, FreeStyle and FreeStyle Flash Blood Glucose FEW13-002, and FED13-006. These lots were distributed Meters: Abbott is conducting a recall for the FreeStyle nationwide to hospitals, infusion clinics, patients, and Blood Glucose Meter and the FreeStyle Flash Blood home health agencies in the United States and all have the Glucose Meter. When used with the Abbott FreeStyle test same NDC code (54092-701-04) and same expiration date strips, the FreeStyle Blood Glucose Meter and the FreeStyle of 10/15 (Oct 2015). Flash Blood Glucose Meter may produce mistakenly low VPRIV is a hydrolytic lysosomal glucocerebroside-specific blood glucose results. enzyme indicated for long-term enzyme replacement FreeStyle and FreeStyle Flash Blood Glucose Meters have therapy for pediatric and adult patients with type 1 not been in production since 2010. Abbott began notifying Gaucher disease. VPRIV is supplied as a sterile, users on Feb. 19, 2014, immediately after the issue was preservative-free, lyophilized powder in single-use vials, for discovered. intravenous use. Abbott recommends the following actions for people with Customers should locate and remove all affected product meters affected by this recall: from their facility and/or residence. Affected product • Immediately contact Abbott Diabetes Care at 1-888- should be returned by contacting Shire at 1-888-899-9293 345-5364 to obtain a replacement meter. (Monday through Friday between the hours of 8:00am and • If the only meter available to you is an affected meter, 5:00pm Eastern Time). Shire has significant quantities of continue to test your blood glucose as recommend by VPRIV to replace any affected product. Shire does not your doctor while you wait for your replacement meter. anticipate any disruption in supply as a result of this When using an affected meter, follow the precautions voluntary recall. (3/14/14) and recommendations in the press release. • If you have access to an alternative glucose meter, Reduce Weight Fruta Planta: MyNicKnaxs, LLC noti- immediately discontinue use of the affected meter and fied the public it is recalling all lots of "Reduce Weight take the necessary steps to continue to monitor your Fruta Planta". The FDA lab analysis of the product found blood sugar with the alternative meter. Reduce Weight Fruta Planta to contain 10.2 mg of phenol- • For users of the OmniPod Insulin Management System phthalein. Phenolphthalein was once an ingredient used in with the built-in FreeStyle Blood Glucose Meter, refer over-the-counter laxatives. Due to concerns of carcinogen-

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 icity, Phenolphthalein is not currently approved for mar- safe and effective” after studies indicated that it presented keting in the United States. This undeclared ingredient a potential cancer-causing (carcinogenic) risk. makes Reduce Weight Fruta Planta an unapproved new Magic Slim is a product promoted and sold for weight loss drug for which safety and efficacy have not been estab- and sold on various websites, including lished. Consumption of this product could include poten- www.slimbeautyusa.com, and in some retail stores. See the tially serious gastrointestinal disturbances, irregular heart- FDA Public Notification for additional information, includ- beat, and cancer with long-term use. ing a product photo. Customers are advised to immediately discontinue use. Consumers should stop using this product immediately and Consumers with questions should contact mynicknaxs at throw it away. Consumers who have experienced any nega- 386-337-8142 or via e-mail at [email protected], Mon- tive should consult a health care professional as day - Friday, 2pm - 7:00 pm, EDT. (2/14/14) soon as possible. (1/22/14)

Mega Slim Herbal Appetite-Management Capsules: Dream Body Slimming Capsules: The FDA is advising YoungYou International notified the public it is recalling consumers not to purchase or use Dream Body Slimming Mega Slim Herbal Appetite Management Pills. A FDA la- Capsule, a product promoted and sold for weight loss on boratory report indicated the presence of DMAA in Mega various websites and in some retail stores. FDA laboratory Slim Herbal Appetite Management. DMAA is also known analysis confirmed that Dream Body Slimming Capsule as 1, 3-dimethylamylamine, methylhexanamine or gerani- contains sibutramine. Sibutramine is a controlled sub- um extract. DMAA is commonly used as a stimulant, pre- stance that was removed from the market in October 2010 workout, and weight loss ingredient in dietary supplement for safety reasons. The product poses a threat to consumers products. The FDA has warned that DMAA is potentially because sibutramine is known to substantially increase dangerous to health as it might cause a rise in blood pres- blood pressure and/or pulse rate in some patients and may sure or other cardiovascular problems such as shortness of present a significant risk for patients with a history of cor- breath, tightening in the chest, or heart attack. The FDA onary artery disease, congestive heart failure, arrhythmias, has also warned that DMAA is an unapproved dietary in- or stroke. This product may also interact, in life- gredient. To learn more, please review the FDA’s advisory threatening ways, with other medications a consumer may on DMAA: be taking. http://www.fda.gov/food/dietarysupplements/qadietarysu Dream Body Slimming Capsule is a product promoted and pplements/ucm346576.htm. sold for weight loss and sold on various websites, including Mega Slim Herbal Appetite Management is packaged in www.slimbeautyusa.com, and in some retail stores. See the white bottles with 30 white capsules. The affected lots in- FDA Public Notification for additional information, includ- clude the following Bar Code 736211614094 and expiration ing a product photo. date of June 2014. Affected product was sold from Septem- Consumers should stop using this product immediately and ber 15, 2013 through January 23, 2014. Mega Slim Herbal throw it away. Consumers who have experienced any nega- Appetite Management was made available to consumers tive side effects should consult a health care professional as only through the YoungYoucorp.com website. soon as possible. (1/22/14) YoungYou is notifying its customers by email and is asking for return of all recalled product to its facility in California. StemAlive 90 Capsules: Stemvida, of Ontario, Califor- Consumers in possession of the Mega Slim Herbal Appetite nia, has recalled StemAlive 90 Capsules, found to contain Management product subject to this recall are advised to undeclared milk. People who have an allergy or severe sen- immediately stop using the product and return it to sitivity to milk (bovine colostrum) run the risk of a serious YoungYou. (1/31/14) or life-threatening allergic reaction if they consume this product. StemAlive was distributed in Arizona, California, Magic Slim: The FDA is advising consumers not to pur- Colorado, Florida, New Jersey, New York, Nevada, Okla- chase or use Magic Slim, a product promoted and sold for homa, Texas, and Utah. weight loss, sold on various websites and in some retail The product is in a white plastic bottle with a white lid and stores. FDA laboratory analysis confirmed that Magic Slim the brand is StemVida International with a white and gold contains sibutramine. Sibutramine is a controlled sub- label. The lot numbers and expiration dates are 8419 stance that was removed from the market in October 2010 (Exp.05/2015 and 06/2015), 8486 (Exp.07/2015), 8535 for safety reasons. The product poses a threat to consumers (Exp. 08/2015), 8598 (Exp. 10/2015), 8652 (Exp. because sibutramine is known to substantially increase 12/2015), 8863 (Exp. 01/2016 and 02/2016), 8872 (Exp. blood pressure and/or pulse rate in some patients and may 03/2016), 8873 (Exp. 04/2016 and 05/2016), 9040 (Exp. present a significant risk for patients with a history of cor- 08/2016 and 09/2016), 9258 (Exp. 10/2016), and 9314 onary artery disease, congestive heart failure, arrhythmias, (Exp. 11/2016). The lot number and expiration date is or stroke. These products may also interact, in life- printed in black ink at the bottom of the label. threatening ways, with other medications a consumer may Consumers who have purchased StemAlive 90 Capsules are be taking. urged to return it to the company for a replacement or re- Laboratory analysis also confirmed that Magic Slim con- fund. Consumers with questions may contact the company tains phenolphthalein. Phenolphthalein was an ingredient at 888-950-8432 between the hours of 9:00am and in some OTC laxative products until 1999, when FDA re- 8:30pm PST. (1/19/14) classified the ingredient as “not generally recognized as

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 Liptruzet—Packaging Defects: All lots of Liptruzet states by Midwest Wholesale from August 1, 2013 through (atorvastatin/ezetimibe) are being recalled by Merck in the October 2013. For a list of products and lot numbers in- United States and Puerto Rico due to packaging defects. cluded in this recall, see the Firm Press Release. The recall includes all products that have been distributed Consumers should stop using this product immediately and since its introduction to the market in May of 2013 and throw it away. Consumers who have experienced any nega- includes all strengths. Liptruzet is available as 10/10, tive side effects should consult a health care professional as 10/20, 10/40, and 10mg/80mg oral tablets. The packaging soon as possible. Consumers with questions regarding this is made up of laminate foil pouches that may allow mois- recall can contact Midwest Wholesale by phone (888-514- ture or air in, which could cause the efficacy of the medica- 7110), Monday through Friday, 9:00am-5:00pm, Central tion to decrease or change the characteristics of the drug. Time. (1/10/14) The potential of such contamination is remote and no ad- verse events have been reported with the use of this drug Truebalance and Truetrack Blood Glucose Meters: thus far. Nipro Diagnostics initiated a voluntary recall and This recall will completely diminish the entire stock of replacement of a limited number of TRUEbalance and Liptruzet. However, both ingredients of this drug combina- TRUEtrack Blood Glucose Meters distributed both in the tion are available as separate products. The FDA and the United States and outside the United States. manufacturer are also not advising that patients stop tak- The company determined that certain isolated ing Liptruzet and are encouraging patients to discuss any TRUEbalance and TRUEtrack Blood Glucose Meters have questions or concerns with their health care provider. an incorrect factory-set unit of measure that displays the Merck is working with the FDA to have Liptruzet back on glucose result in mmol/L rather than mg/dl. If a consumer the market as soon as possible. (1/14/14) were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than t:slim Insulin Cartridges—Potential Leakage: Tan- expected blood glucose result. dem Diabetes Care announced that it is initiating a volun- There are 501 affected TRUEbalance meters and 105 tary recall of specific lots of insulin cartridges that are used affected TRUEtrack meters that were distributed in the with the t:slim Insulin Pump. The affected cartridges may United States from September 2008 to May 2013. The be at risk for leaking. A cartridge leak could potentially re- company is sending notifications to pharmacies, durable sult in the device delivering too much or too little insulin, medical equipment providers, mail order companies, and which can lead to a serious adverse event. distributors where the TRUEbalance and TRUEtrack Affected lots were shipped on or after December 17, 2013. meters are recommended or sold in the United States. The affected lots represent approximately 4,746 boxes of Consumers who have a TRUEbalance or TRUEtrack meter cartridges (10 cartridges per box). should: Customers should discontinue using cartridges labeled • Check to confirm if they have an affected TRUEbalance with the affected lots. Please see the Firm Press Release for or TRUEtrack meter by obtaining the serial number the complete listing. Customers who received affected car- from the serial number label on the back of the meter tridges are being contacted by the company or its author- and visiting www.NiproDiagnostics.com/product- ized distributors and asked to call Tandem Technical Sup- notice or by calling Stericycle toll-free at 1-866-236- port to receive replacement cartridges at no charge. Tan- 4518. dem expects to have sufficient quantities of cartridges to • If the consumer has an affected TRUEbalance or replace affected lots in a timely manner. Tandem Customer TRUEtrack meter, please call Stericycle to verify serial Support is available 24 hours a day, 7 days a week at 1-877- number and to expedite return and replacement of 801-6901. (1/14/14) these affected TRUEbalance and TRUEtrack meters at no charge. Dietary Supplements for Sexual Enhancement: Consumers may continue to test blood glucose using any Midwest Wholesale is voluntarily recalling the following other Nipro Diagnostics blood glucose meter not included products: Boost Ultra, XZone Gold, Sexy Monkey, Triple in this recall while waiting for their replacement meter to MiracleZen Platinum, Magic for Men, "New" Extenze, and arrive. Only use test strips that are intended for use with New XZen Platinum. The FDA’s analysis found these prod- their blood glucose meter. (1/8/14) ucts to contain undeclared Sildenafil and/or Tadalafil, the active ingredients in FDA-approved prescription drugs Gardasil Vaccination: One lot of Gardasil vaccine used to treat erectile dysfunction. These undeclared ingre- (human papilomavirus quadrivalent [types 6, 11, 16, and dients may interact with nitrates found in some prescrip- 18]) was recalled voluntarily by its manufacturer, Merck tion drugs, such as nitroglycerin, and may lower blood Sharp & Dohme Corp. The product was recalled because of pressure to dangerous levels. Men with diabetes, high the potential presence of glass particles found in a small blood pressure, high cholesterol, or heart disease often take number of vials. The affected lot was manufactured and nitrates. distributed between August 20, 2013 and October 9, 2013. These products are labeled and intended to be used as die- At this time, no other lots are affected. There is a slight risk tary supplements for sexual enhancement. The products of an injection site reaction if a patient receives the are packaged in 1 capsule blister packs, 3 pill bottles, 6 pill vaccination. However, this product’s sterility is not bottles, 12 pill bottles, and 30 tablet boxes. These products impacted. If any of the select vaccines have already been were distributed to 20 selected retail locations in several administered, revaccination is not needed. Gardasil’s

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 supply should not be interrupted by this recall. All have diabetes mellitus that is difficult to control or very customers are being asked to check their supply and follow high levels of triglycerides in the blood the steps listed in the notification. (12/31/13) (hypertriglyceridemia) that can lead to inflammation of the pancreas. Approved Drugs Because of the risks associated with the development of neutralizing antibodies and lymphoma, Myalept is Please access www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm available only through the Myalept Risk Evaluation and for in-depth drug approval information. Mitigation Strategy (REMS) Program. Under this REMS program, prescribers must be certified with the program by Xartemis XR: Xartemis XR has been approved by the enrolling in and completing training. Pharmacies must be FDA to manage acute pain in patients who require opioid certified with the program and only dispense Myalept after treatment in which alternative therapy options are inade- receipt of the Myalept REMS Prescription Authorization quate. Xartemis XR, generic name oxycodone/ Form for each new prescription. acetaminophen, are available as 7.5mg/325mg extended- Myalept is also approved with a Medication Guide and release tablets and are manufactured by Mallinckrodt. This instructions for use that provides patients with important medication does have a boxed warning stating the risk of information about the medication. The guide will be addiction, abuse, and misuse. The boxed warning also lists distributed each time a patient fills a prescription. the risk of respiratory depression that may be life- Myalept is marketed by San Diego-based threatening, accidental overdose, hepatotoxicity, and neo- Pharmaceuticals, L.L.C. (2/25/14) natal withdrawal syndrome. Due to the seriousness of the warning, this drug will be dispensed with a medication Northera: The FDA approved Northera capsules guide. (3/13/14) (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often de- Qudexy XR: Qudexy XR, generic name topiramate, has bilitating drop in blood pressure upon standing that is as- been approved by the FDA to treat partial-onset seizures sociated with Parkinson's disease, multiple-system atro- (POS) as adjunctive therapy or primary generalized tonic- phy, and pure autonomic failure. clonic seizures in patients who are 10 years or older as Symptoms of NOH include dizziness, lightheadedness, monotherapy. This new once-daily, extended-release cap- blurred vision, fatigue and fainting when a person stands. sule is also approved for the treatment of POS, primary Northera has a boxed warning to alert health care profes- generalized tonic-clonic seizures, and seizures associated sionals and patients about the risk of increased blood pres- with Lennox-Gastaut syndrome in patients who are 2 years sure while lying down (supine hypertension), a common or older. Qudexy XR is manufactured by Upsher-Smith problem that affects people with primary autonomic failure Laboratories and is anticipated to be available in the se- and can cause stroke. It is essential that patients be re- cond quarter 2014. (3/12/14) minded that they must sleep with their head and upper body elevated. Supine blood pressure should be monitored Tivorbex: Tivorbex, a new non-steroidal anti- prior to and during treatment and more frequently when inflammatory drug, was approved by the FDA to treat adult increasing doses. patients with mild-to-moderate acute pain. Tivorbex, ge- Northera received orphan-product designation from the neric name indomethacin, is manufactured by Iroko Phar- FDA because it is intended to treat a rare disease or condi- maceuticals and is available as 20mg and 40mg capsules. tion. The dosage strengths of this medication are 20% lower Northera is made by Charlotte-based Chelsea Therapeutics than already approved indomethacin products on the mar- Inc. (2/18/14) ket. Tivorbex has been issued a boxed warning stating the risk of serious cardiovascular and gastrointestinal events Hetlioz: The FDA approved Hetlioz (tasimelteon), a and will be dispensed with a patient medication guide. melatonin receptor agonist, to treat non-24- hour sleep- (2/26/14) wake disorder (“non-24”) in totally blind individuals. Non- 24 is a chronic circadian rhythm (body clock) disorder in Myalept: The FDA approved Myalept ( for patients who are blind that causes problems with the tim- injection) as replacement therapy to treat the ing of sleep. This is the first FDA approval of a treatment complications of deficiency, in addition to diet, in for the disorder. patients with congenital generalized or acquired Non-24 occurs in persons who are completely blind. Light generalized lipodystrophy. does not enter their eyes and they cannot synchronize their Generalized lipodystrophy is a condition associated with a body clock to the 24-hour light-dark cycle. lack of fat tissue. Patients with congenital generalized Those with the disorder may have difficulty falling asleep lipodystrophy are born with little or no fat tissue. Patients or staying asleep, and may wake up groggy or feeling as if with acquired generalized lipodystrophy generally lose fat they need more rest. People with non-24 may find their tissue over time. Because the hormone leptin is made by fat sleep patterns reversed–needing to sleep during the day tissue, patients with generalized lipodystrophy have very and to be awake at night. low leptin levels. Leptin regulates food intake and other Hetlioz can impair activities that require complete mental hormones, such as insulin. alertness. Hetlioz should be taken at the same time every Patients with both types of generalized lipodystrophy often develop severe insulin resistance at a young age and may 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 night before bedtime and activities should be limited after Generic Micardis Approved by FDA: The FDA has taking the drug. granted approval of telmisartan, the generic form of Hetlioz is manufactured by Vanda Pharmaceuticals, Inc. of Micardis. Telmisartan is indicated to treat hypertension as Washington, D.C. (1/31/14) well as lower blood pressure in patients who cannot take ACE inhibitors and have cardiovascular risk. Telmisartan is Farxiga: The FDA approved Farxiga (dapaglifozin) tablets manufactured by Actavis and is supplied as 20, 40, & 80mg to improve glycemic control, along with diet and exercise, oral tablets. (1/8/14) in adults with type 2 diabetes. Type 2 diabetes affects about 24 million people and Generic Detrol LA Approval: The generic form of accounts for more than 90 percent of diabetes cases Detrol LA, tolterodine tartrate, has been approved by the diagnosed in the United States. Over time, high blood sugar FDA to treat patients who have an overactive bladder. This levels can increase the risk for serious complications, medication is supplied as 2mg and 4 mg extended-release including heart disease, blindness, and nerve and kidney capsules. (1/3/14) damage. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the New Indications kidney, increases glucose excretion, and lowers blood glucose levels. FDA Indication Expanded for Kalydeco: Kalydeco Farxiga should not be used to treat people with type 1 (ivacaftor) tablets, manufactured by Vertex diabetes; those who have increased ketones in their blood Pharmaceuticals, have been approved by the FDA to now or urine (diabetic ketoacidosis); or those with moderate or treat cystic fibrosis in patients who are six years of age or severe renal impairment, end stage renal disease, or older and have one of eight additional mutations in the patients on dialysis. cystic fibrosis transmembrane conductance regulator An increased number of bladder cancers were diagnosed (CFTR) gene. The mutation must be with one of the among Farxiga users in clinical trials so Farxiga is not following: G551D, G1244E, G1349D, G178R, G551S, recommended for patients with active bladder cancer. S1251N, S1255P, S549N, or S549R. Before, Kalydeco was Patients with a history of bladder cancer should talk to only approved by the FDA to treat cystic fibrosis with a their physician before using Farxiga. Farxiga can cause G551D mutation in the CFTR gene in patients who were six dehydration, leading to a drop in blood pressure years of age or older. (2/24/14) (hypotension) that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with New Indication for Imbruvica: The FDA today ex- impaired renal function, and patients on diuretics to treat panded the approved use of Imbruvica (ibrutinib) for other conditions appeared to be more susceptible to this chronic lymphocytic leukemia (CLL) patients who have risk. received at least one previous therapy. The FDA is requiring six post-marketing studies for CLL is a rare blood and bone marrow disease that usually Farxiga. gets worse slowly over time, causing a gradual increase in Farxiga is marketed by Bristol-Meyers Squibb Company, white blood cells called B lymphocytes, or B cells. The Na- Princeton, N.J. and AstraZeneca Pharmaceuticals L.P., tional Cancer Institute estimates that 15,680 Americans Wilmington, Del. (1/8/14) were diagnosed and 4,580 died from the disease in 2013. Imbruvica works by blocking the enzyme that allows cancer

New Generics cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of FDA Approves Generic Evista Tablets: The FDA has blood cancer, if those patients received at least one prior approved Teva Pharmaceutical’s raloxifene 60 mg tablets, therapy. the generic version of Evista is indicated for the treatment Under the agency’s accelerated approval process, the FDA and prevention of osteoporosis, reduction in the risk of in- may approve a drug based on a surrogate or intermediate vasive breast cancer in postmenopausal women with osteo- endpoint that is reasonably likely to predict clinical benefit. porosis, and reduction in the risk of invasive breast cancer Drugs receiving accelerated approval are usually subject to in postmenopausal women at high risk of invasive breast an agreement to conduct confirmatory trials verifying and cancer. Evista carries a Boxed Warning regarding the in- describing clinical benefit. Imbruvica for CLL also received creased risk of venous thromboembolism and death from priority review and orphan-product designation because stroke and is dispensed with a patient Medication Guide. the drug demonstrated the potential to be a significant im- (3/4/14) provement in safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease, Doxercalciferol (Generic Hectorol): Doxercalciferol, respectively. the generic form of Hectorol, is now available through the Imbruvica is manufactured by Sunnyvale, Calif.-based manufacturer Sandoz. The drug is available as 4mcg/2mL Pharmacyclics. (2/12/14) single-dose vials and is indicated to treat secondary hy- perparathyroidism in patients who have chronic kidney FDA Approval of Mekinist for Melanoma: The FDA disease and are on dialysis. (2/7/14) approved Mekinist (trametinib) in combination with 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 Tafinlar (dabrafenib) to treat patients with advanced mela- of using Eliquis outweigh any potential risks for patients noma that is unresectable (cannot be removed by surgery) with nonvalvular atrial fibrillation. Due to the necessary or metastatic (late-stage). REMS, this drug will be dispensed with a patient medica- In May 2013, the FDA approved both drugs as single agents tion guide. Eliquis is available as oral tablets and manufac- to treat patients with unresectable or metastatic melanoma. tured by Bristol-Myers Squibb. (3/17/14) Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease. The National Acetaminophen Combination Products—FDA Safe- Cancer Institute estimated that 76,690 Americans would be ty Statement: The FDA is recommending health care diagnosed with melanoma and 9,480 would die from the professionals discontinue prescribing and dispensing pre- disease in 2013. scription combination drug products that contain more Women of child bearing potential should be advised that than 325 milligrams of acetaminophen per tablet, capsule, Mekinist and Tafinlar can cause birth defects in a develop- or other dosage unit. There is no available data to show ing fetus. Men and women should also be advised that that taking more than 325mg of acetaminophen per dosage Mekinist and Tafinlar treatment may cause infertility. unit provides additional benefit that outweighs the added The FDA approved the combination of Mekinist and risk of liver injury. Furthermore, limiting the amount of Tafinlar under the agency’s accelerated approval program, acetaminophen per dosage unit will reduce the risk of se- which allows the FDA to approve a drug to treat a serious vere liver injury from inadvertent acetaminophen over- disease based on clinical data showing that the drug has an dose, which can lead to liver failure, liver transplant, and effect on a surrogate endpoint that is reasonably likely to death. predict a clinical benefit to patients. This program provides Cases of severe liver injury with acetaminophen have oc- earlier patient access to promising new drugs while the curred in patients who took more than the prescribed dose company conducts confirmatory clinical trials. The FDA of an acetaminophen-containing product in a 24-hour pe- also reviewed this combination of drugs under the agency’s riod; took more than one acetaminophen-containing prod- priority review because they demonstrated the potential to uct at the same time; or drank alcohol while taking aceta- be a significant improvement in safety or effectiveness in minophen products. the treatment of a serious condition. This category of prescription drugs combines acetamino- Mekinist and Tafinlar are marketed by GlaxoSmithKline, phen with another ingredient (most often an opioid), and based in Research Triangle Park, N.C. (1/10/14) these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, New Indication Approved for Feiba: Feiba (anti- or pain following dental procedures. inhibitor coagulant complex), was approved by the FDA to Acetaminophen is also widely used as an OTC pain and be used as maintenance prophylaxis in patients with fever medication, and is often combined with other ingre- hemophilia A or B who have developed inhibitors to reduce dients, such as cough and cold ingredients. FDA will ad- or prevent the frequency of bleeding episodes. This dress OTC acetaminophen products in another regulatory medication is already FDA approved to control action. Many consumers are often unaware that many spontaneous bleeding episodes or cover surgical products (both prescription and OTC) contain acetamino- interventions in the same group of patients. Feiba is phen, making it easy to accidentally take too much. manufactured by Baxter. (1/7/14) More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combi- Indication Expanded for Isentress: Isentress, generic nation drug products containing more than 325mg of acet- name raltegravir, is now approved by the FDA to treat HIV- aminophen per dosage unit remain available. In the near 1 infection in combination with other antiretroviral future, FDA intends to institute proceedings to withdraw therapies for patients who are 4 weeks of age or older. approval of prescription combination drug products con- Before, Isentress was used for the same indication but only taining more than 325mg of acetaminophen per dosage for patients who were at least 2 years of age and weighed unit that remain on the market. FDA recommends that 10kg or more. This medication is manufactured by Merck health care providers consider prescribing combination and is available as oral tablets, chewable tablets, and as an drug products that contain 325mg or less of acetamino- oral suspension. (12/26/13) phen. FDA also recommends that when a pharmacist re- ceives a prescription for a combination product with more Revised Labeling/ than the recommended amount, that they contact the pre- scriber to discuss a product with a lower dose of aceta- Prescribing Information minophen. A two tablet or two capsule dose may still be

prescribed, if appropriate. In that case, the total dose of Eliquis Labeling Revised: Eliquis, generic name acetaminophen would be 650mg (the amount in two apixaban, is now approved by the FDA in patients who 325mg dosage units). When making individual dosing de- have had hip or knee surgery for prophylaxis treatment of terminations, health care providers should always consider deep vein thrombosis. In addition, an updated boxed warn- the amounts of both the acetaminophen and the opioid ing was added to the labeling stating the increased risk of components in the prescription combination drug product. epidural or spinal hematoma that could result in long-term (1/14/14) paralysis in patients administered neuraxial anesthesia. This medication requires REMS to ensure that the benefits 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

Miscellaneous

FDA Allows Iclusig Back onto the Market: Iclusig, generic name ponatinib, is now on the market again in the United States after having its availability suspended for several months due to patients experiencing vascular oc- clusion events that were being increasingly reported. The FDA required Ariad Pharmaceuticals (the manufacturer of Iclusig) to revise the prescribing information and undergo REMS before approval of this product again. The prescrib- er’s information now contains a boxed warning regarding the risk of vascular occlusion problems and a change in the indication. Iclusig is now approved to treat adults with re- fractory chronic myeloid leukemia and Philadelphia chro- mosome-positive acute lymphoblastic leukemia. Other changes in the prescriber’s information include new dosing recommendations and an updated safety profile. The man- ufacturer is currently shipping to its exclusive specialty pharmacy, Biologics, and is beginning to fill prescriptions and distribute the medication. (1/20/14)

U.S. Food and Drug Administration’s

MedWatch Adverse Event Reporting Program

Please contact MedWatch to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, die- tary supplement or cosmetic. You can also report suspected counterfeit medical products to the FDA through MedWatch. ______

To report a serious problem:

1-800-332-1088 (phone) 1-800-FDA-0178 (fax) ______

MedWatch online:

http://www.fda.gov/MedWatch/report.htm ______

By mail (use postage-paid FDA Form 3500):

MedWatch 5600 Fishers Lane Rockville, MD 20857

FUTURE DRUG RELEASES LISTED ON NEXT PAGE.

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

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

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Route of Generic Name Brand Name Manufacturer Indication(s) / Use Approval / Administration Market Date nedocromil Alocril Allergan Ophthalmic Allergies approved† Avandia GlaxoSmithKline Oral Type 2 diabetes approved† Osteoporosis, raloxifene Evista Lilly Oral approved† breast cancer risk reduction Hyperphosphatemia associated lanthanum carbonate Fosrenol Shire Oral 1Q2014 with chronic kidney disease (CKD) valganciclovir Valcyte Roche Oral Cytomegalovirus 1Q2014 estradiol Vivelle-Dot Novartis Transdermal Symptoms of menopause 1Q2014 transdermal patch sevelamer Renvela Genzyme Oral CKD MAR 2014 carbonate tablet eszopiclone Lunesta Sepracor Oral Insomnia APR 2014 Orapred Asthma, atopic dermatitis, prednisolone Shionogi Pharma Oral APR 2014 ODT allergic rhinitis diclofenac sodium Nuvo Research, Pennsaid Transdermal Osteoarthritis of the knees APR 2014 viscous solution Mallinckrodt mesylate Viracept ViiV Healthcare Oral Antiretroviral APR 2014 Celebrex Pfizer Oral Osteoarthritis, pain MAY 2014 hydromorphone Exalgo Mallinckrodt Oral Moderate to severe pain MAY 2014 Gastroesophageal reflux esomeprazole Nexium AstraZeneca Oral MAY 2014 disease, ulcers cyclosporine Restasis Allergan Ophthalmic Chronic dry eye MAY 2014 Procter & risedronate Actonel Oral Osteoporosis JUN 2014 Gamble mometasone furoate Nasonex Schering Nasal Allergies JUL 2014 bimatoprost Lumigan Allergan Ophthalmic Glaucoma, ocular hypertension AUG 2014 sevelamer hydrochloride Renagel Genzyme Oral CKD SEP 2014 amlodipine/valsartan Exforge Novartis Oral High blood pressure OCT 2014 amlodipine/valsartan/ Exforge HCT Novartis Oral High blood pressure OCT 2014 HCTZ Attention deficit hyperactivity guanfacine ER tablets Intuniv Actavis Oral DEC 2014 disorder (ADHD) lovastatin/niacin Advicor Abbott Oral Cholesterol 2014 mesalamine Asacol Warner Chilcott Oral Ulcerative colitis, proctitis 2014 valsartan Diovan Novartis Oral High blood pressure 2014 paliperidone ER Invega Janssen Oral Schizophrenia 2014 ethinyl estradiol/ Loestrin Warner Chilcott Oral Birth control pill 2014 norethindrone 24 Fe oxycodone ER Oxycontin Purdue Oral Moderate to severe pain 2014 omega-3-acid ethyl esters Lovaza GlaxoSmithKline Oral Cholesterol 1Q2015 memantine tablet Namenda Forest Oral Alzheimer’s disease JAN 2015 trandolapril/verapamil Tarka Abbott Oral High blood pressure FEB 2015 colesevelam tablet Welchol Daiichi Sankyo Oral Cholesterol MAR 2015 aripiprazole Abilify Otsuka Oral Psychiatric conditions APR 2015 Chemo-associated nausea & aprepitant Emend Merck Oral vomiting; prevention of APR 2015 post-op nausea & vomiting oxybutynin Oxytrol Watson Transdermal Overactive bladder APR 2015 linezolid Zyvox Pfizer Oral Bacterial infections MAY 2015 ciprofloxacin/ Cipro-HC Bayer Otic Bacterial ear infections JUN 2015 hydrocortisone gemifloxacin Factive Cornerstone Oral Antibiotic JUN 2015 Boehringer aspirin/dipyridamole Aggrenox Oral Stroke prevention JUL 2015 Ingelheim testosterone Androgel 1% Solvay Topical Hormone replacement AUG 2015 Avodart GlaxoSmithKline Oral Benign prostatic hyperplasia 4Q2015 dutasteride/tamsulosin Jalyn GlaxoSmithKline Oral Benign prostatic hypertrophy 4Q2015 mesalamine DR Asacol HD Warner Chilcott Oral Ulcerative colitis NOV 2015

10

Ortho-McNeil- almotriptan Axert Oral Migraine NOV 2015 Janssen Endo Pharma- frovatriptan succinate Frova Oral Migraine NOV 2015 ceuticals Tracleer Actelion Oral Pulmonary arterial hypertension NOV 2015 norgestimate/ Ortho Tri- Ortho Mcneil Oral Birth control pill DEC 2015 ethinyl estradiol Cyclen Lo Janssen olopatadine Patanol Alcon Ophthalmic Allergic conjunctivitis DEC 2015 metformin ER Glumetza Santarus Oral Type 2 diabetes FEB 2016 darifenacin Enablex Novartis Oral Overactive bladder MAR 2016 rosuvastatin Crestor AstraZeneca Oral Cholesterol MAY 2016 armodafinil Nuvigil Teva Oral Sleep disorders JUN 2016 clindamycin/ Ziana Medicis Topical Acne JUL 2016 Advair Asthma, chronic obstructive /salmeterol GlaxoSmithKline Inhalation AUG 2016 Diskus pulmonary disease (COPD) doxycycline Oracea Lupin, Mylan Oral Rosacea AUG 2016 olmesartan/amlodipine Azor Daiich Sankyo Oral High blood pressure OCT 2016 olmesartan Benicar Daiichi Sankyo Oral High blood pressure OCT 2016 olmesartan/HCTZ Benicar HCT Daiichi Sankyo Oral High blood pressure OCT 2016 quetiapine ER tablet Seroquel XR AstraZeneca Oral Antipsychotic NOV 2016 eletriptan Relpax Pfizer Oral Migraines DEC 2016 Hyperparathyroidism, cinacalcet tablet Sensipar Amgen Oral DEC 2016 hypercalcemia ezetimibe Zetia Merck Oral Cholesterol DEC 2016 abiraterone acetate Zytiga Janssen Oral Prostate cancer DEC 2016 rasagiline Azilect Teva Oral Parkinson’s disease FEB 2017 ezetimibe/simvastatin Vytorin Merck Oral Cholesterol APR 2017 atomoxetine Strattera Lilly Oral ADHD MAY 2017 Actavis, Amneal, sildenafil Viagra Apotex, Oral Erectile dysfunction DEC 2017 Dr. Reddy’s Levitra Teva Oral Erectile dysfunction OCT 2018 testosterone gel Fortesta Actavis Topical Male hypogonadism NOV 2018 Diabetic peripheral neuropathy, pregabalin Lyrica Pfizer Oral postherpetic neuralgia, DEC 2018 seizures, fibromyalgia metformin/rosiglitazone Avandamet GlaxoSmithKline Oral Type 2 diabetes uncertain rosiglitazone/glimepiride Avandaryl GlaxoSmithKline Oral Type 2 diabetes uncertain phenoxybenzamine Dibenzyline Roxane Oral Pheochromocytoma uncertain rivastigmine Alzheimer’s disease & Exelon Novartis Oral uncertain solution Parkinson’s disease alendronate/ Fosamax Merck Oral Osteoporosis uncertain cholecalciferol Plus D Lamictal ODT Actavis Oral Seizures uncertain ODT

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

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated FDA Route of Filing / Drug Name Manufacturer Indication(s) / Use Administration Approval / Market Date Impavido (miltefosine) Paladin Oral Treatment of leishmaniasis approved† Chelsea Northera (droxidopa) Oral Neurogenic orthostatic hypotension approved† Therapeutics Hyponatremia associated with heart failure, Lixar (lixivaptan) Cornerstone Oral syndrome of inappropriate 1Q2014 antidiuretic hormone Oralair (grass pollen allergen Stallergenes, Freeze-dried extract of grass pollen Sublingual 1Q2014 immunotherapy) Paladini allergens for allergic rhinitis Probuphine Titan, SubQ Opioid dependence in adults 1Q2014 (buprenorphine SR) Braeburn Striverdi Respimat Boehringer Inhalation Asthma, COPD 1Q2014 (olodaterol) Ingelheim

11

Ragwitek (ALK ragweed/ Merck, Sublingual Allergies caused by ragweed allergen MAR 2014 ambrosia artemisifolia) ALK-Abello Forest, Schizophrenia, acute treatment of TBA (cariprazine) Gedeon Oral manic or mixed episodes associated with bi- 2Q – 3Q2014 Richter polar I disorder Glaxo Eperzan, Syncria () SubQ Type 2 diabetes APR 2014 SmithKline Prevention of cardio- and cerebro-vascular TBA Pozen Oral events, reduce risk of gastric ulcers in pa- APR 2014 (omeprazole/aspirin DR) tients at risk of aspirin-induced gastric ulcers Glaxo TBA (umeclidinium) Inhalation COPD, asthma APR 2014 SmithKline Cardiovascular event prevention MAY – JUN TBA (vorapaxar sulfate) Merck Oral in select patients 2014 MAY – JUN Zontivity (vorapaxar sulfate) Merck Oral Myocardial infarction 2014 Acute bacterial skin infections, TBA (tedizolid phosphate) Trius Oral JUN 2014 skin structure infections Hypoactive sexual desire disorder Girosa (filbanserin) Sprout Oral 3Q2014 in premenopausal women Targiniq ER (oxyco- Purdue Oral Management of chronic pain 3Q2014 done/naltrexone) TBA (tavaborole) Anacor Topical Oncyhomycosis JUL 2014 AstraZeneca, TBA (naloxegol) Oral Opioid-induced constipation SEP 2014 Nektar TBA () Eli Lilly SubQ Type 2 diabetes SEP – OCT 2014 TBA Helsinn, Eisai Oral -induced nausea & vomiting 4Q2014 (palonosetron/netupitant) AstraZeneca, Xigduo Bristol Myers Oral Type 2 diabetes 4Q2014 (dapagliflozin/metformin) Squibb Stroke & systemic embolic events 4Q2014 – Savaysa (edoxaban tosylate) Daiichi Sankyo Oral risk reduction, deep vein thrombosis, & JAN 2015 venous thromboembolism TBA (nebivolol/valsartan) Forest Oral Hypertension DEC 2014 Grastek (Timothy grass pollen Merck; ALK- Prevention of allergies caused by Sublingual 2014 extract/phleum pretense) Abello grass pollen allergen Jublia (efinaconazole) Kaken, Valeant Topical Distal lateral subungal onychomycosis 2014 TBA Janssen Oral Type 2 diabetes 2014 (canagliflozin/metformin) Boehringer TBA (empagliflozin) Ingelheim, Eli Oral Type 2 diabetes 2014 Lilly TBA () Merck Oral Insomnia 2014 Lixiana (edoxaban tosylate) Daiichi Sankyo Oral Stroke prevention in atrial fibrillation 1Q2014 (filing*) Newron, TBA (safinamide) Oral Parkinson’s disease 1Q2014 (filing*) Merck Serono The Medicines JAN – APR 2014 Ionsys (fentanyl) Transdermal Acute postoperative pain Company (filing*) Otitis externa and media with AL-60371 Alcon Otic 2Q2014 (filing*) a tympanostomy tube TBA Diarrhea-predominant JUN 2014 Furiex Oral (eluxadoline dihydrochloride) irritable bowel syndrome (filing*) TBA (patiromer) Relypsa Oral Hyperkalemia in patients with CKD 3Q2014 (filing*) AstraZeneca, Saxadapa Bristol Myers Oral Type 2 diabetes 4Q2014 (filing*) (saxagliptin/dapagliflozin) Squibb Ardea TBA (lesinurad) Biosciences, Oral Hyperuricemia, gout 4Q2014 (filing*) AstraZeneca TBA (obeticholic acid) Intercept Oral Primary biliary cirrhosis, hepatic fibrosis 4Q2014 (filing*) TBA (pimavanserin) Acadia, Biovail Oral Parkinson’s disease psychosis 4Q2014 (filing*) Deovo (head lice treatment) Hatchtech Topical Head lice 2014 (filing*) FP-01 Cerecor Oral Cough 2014 (filing*) SD-101 Scioderm Topical Epidermolysis bullosa 2014 (filing*) TBA (aclidinium Forest, Inhalation COPD 2014 (filing*) bromide/formoterol) Almirall TBA (alfentanil) Orexo Sublingual Pain 2014 (filing*)

12

Helsinn Treatment of cachexia & TBA (anamorelin) Oral 2014 (filing*) Therapeutics anorexia in cancer patients TBA (asfotase alfa) Alexion SubQ Hypophosphotasia 2014 (filing*) Otsuka, Schizophrenia, adjunctive therapy TBA (brexpiprazole) Oral 2014 (filing*) Lundbeck for major depressive disorder TBA (evolocumab) Amgen SubQ Hypercholesterolemia 2014 (filing*) TBA (hydrocodone CR/ Charleston acetaminophen/ Oral Pain (2014 filing*) Laboratories promethazine) TBA (ivabradine) Amgen Oral Chronic heart failure 2014 (filing*) Acute uncomplicated influenza as mono- TBA (nitazoxanide) Romark Oral 2014 (filing*) therapy or in combination with oseltamivir TBA (odanacatib) Merck, Celera Oral Osteoporosis 2014 (filing*) TBA (pradigastat) Novartis Oral Familial chylomicronemia syndrome 2014 (filing*) TBA (rifabutin// RedHill Oral Helicobacter pylori infection 2014 (filing*) undisclosed PPI) Prevention of chemotherapy-induced TBA (rolapitant) OPKO, Tesaro Oral 2014 (filing*) nausea & vomiting TBA (/valsartan Novartis Oral High blood pressure 2014 (filing*) trisodium hemipentahydrate) Accidental overexposure to (5- TBA (uridine triacetate) BTG, Wellstat Oral FU) due to dosing errors or impaired clear- 2014 (filing*) ance of 5-FU from the body Glax- TBA (vilanterol) oSmithKline, Inhalation COPD 2014 (filing*) theravance Warner Zydena (udenafil) Oral Erectile dysfunction 2014 (filing*) Chilcott TBA (omarigliptin) Merck Oral Type 2 diabetes >2014 (filing*) Dainippon TBA (ranirestat) Sumitomo Oral Diabetic peripheral neuropathy >2014 (filing*) Pharma, Eisai Visonac 2014 – 2015 Photocure Topical Acne (methyl aminoevulinate) (filing*) Arimenda Adamas, For- Oral Alzheimer’s dementia 1Q2015 (memantine/donepezil) est Lixilan Sanofi SubQ Type 2 diabetes 4Q2015 (/) Derma Scienc- TBA (aclerastide) Topical Diabetic foot ulcers 2Q2015 (filing*) es TBA (bevenopran) Eli Lilly Oral Opioid-induced constipation 2Q2015 (filing*) APR 2015 – TBA (fasiglifam Takeda Oral Type 2 diabetes MAR 2016 hemihydrates) (filing*) AN-2728 Anacor Topical Psoriasis, atopic dermatitis 2015 (filing*) GW Pharma- Cancer pain; Sativex (nabiximols) ceuticals Oral 2015 (filing*) spasticity in multiple sclerosis (MS) Otsuka Stedicor (azimilide) Forest Oral Ventricular arrhythmia 2015 (filing*) Regeneron, TBA (alirocumab) SubQ Cholesterol 2015 (filing*) Sanofi Aventis TBA (auriclosene) NovaBay Ophthalmic Adenoviral conjunctivitis 2015 (filing*) TBA (bitopertin) Roche Oral Schizophrenia 2015 (filing*) TBA (deferitazole) Shire Oral Iron overload 2015 (filing*) Pearl TBA (glycopyrronium Therapeutics, Inhalation COPD 2015 (filing*) bromide/formoterol) AstraZeneca TBA () Shire Ophthalmic Dry eye 2015 (filing*) TBA (mavoglurant) Novartis Oral Fragile X syndrome 2015 (filing*) TBA (ozenoxacin) Ferrer Topical Skin & skin structure infections 2015 (filing*) TBA (rifabutin/ RedHill Oral Crohn’s disease 2015 (filing*) clarithromycin/clofazimine) Sanochemia, TBA (tolperisone CR) Oral Neuromuscular spasm & spasticity 2015 (filing*) Katama Sanofi Aventis, 2015 Lyxumia (lixisenatide) SubQ Type 2 diabetes Zealand (re-filing*) Atherosclerosis, dyslipidemia, hypercholes- TBA (anacetrapib) Merck Oral >2015 (filing*) terolemia

13

Prana Bio- 2015 – 2016 PBT-2 Oral Huntington’s disease technology (filing*) 2015 – 2016 TBA (langlenatide) Hanmi SubQ Type 2 diabetes (filing*) Ryzodeg (insulin Novo Nordisk SubQ Type 1 & type 2 diabetes 2016 degludec/) Addex TBA (dipraglurant) Oral Levodopa-induced dyskinesia 2016 (filing*) Therapeutics Abbott, TBA (elagolix) Oral Endometriosis 2016 (filing*) Neurocrine TBA (lasmiditan) CoLucid Oral Treatment of migraine 2016 (filing*) TBA (surotomycin) Cubist Oral Clostridium difficile-associated diarrhea 2016 (filing*) Ideglira (insulin Novo Nordisk SubQ Type 2 diabetes 1Q2017 (filing*) degludec/) BCT-197 Novartis Oral COPD >2017 (filing*) BGS-649 Novartis Oral Obese hypogonadotropic hypogonadism >2017 (filing*) LFF-571 Novartis Oral Clostridium difficile infection >2017 (filing*) LIK-066 Novartis Oral Type 2 diabetes >2017 (filing*) QAW-039 Novartis Oral Asthma >2017 (filing*) TBA (amilomotide) Novartis, Cytos SubQ Alzheimer’s disease >2017 (filing*) TBA Novartis Inhalation COPD, asthma >2017 (filing*) (mometasone/indacaterol) Astellas, TBA (roxadustat) Oral Anemia associated with CKD 2018 (filing*) AstraZeneca CM-AT Curemark Oral Autism uncertain Decrease birthing time to vaginal delivery for Misopress (misoprostol) Ferring Vaginal uncertain women who have an unfavorable cervix TBA (perindopril arginine/ Symplmed, Oral Hypertension uncertain amlodipine besylate) XOMA

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

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated FDA Fil- Route of ing / Drug Name Manufacturer Indication(s) / Use Administration Approval / Market Date Sitavig (acyclovir lauriad) BioAlliance Buccal Herpes simplex virus-1 infections approved† Ximino (minocycline ER) Ranbaxy Oral Moderate to severe acne approved† Zecuity ( NuPathe Transdermal Migraine approved† transdermal) GeNOsyl MVG-2000 (ni- GeNO Inhalation Hypoxic respiratory failure in neonate 1Q2014 tric oxide delivery system) TBA (granisetron SR) AP Pharma SubQ Chemotherapy-induced nausea & vomiting 1Q2014 TBA () Eli Lilly SubQ Type 1 & Type 2 diabetes 1Q2014 Levadex Map, Nektar, Inhalation Migraine 2Q2014 (dihydroergotamine) Allergan Afrezza (insulin human [rDNA origin] inhalation MannKind Inhalation Type 1 & type 2 diabetes APR 2014 powder) Flamel Genvir () Oral Herpes simplex virus infection APR 2014 Technologies CompleoTRT (testos- Trimel Nasal Male hypogonadism MAY 2014 terone intranasal) Epanova Omthera, (eicosapentaenoic acid/ Oral High triglycerides MAY 2014 AstraZenca docosahexaenoic acid) MoxDuo IR (mor- QRxPharma, New oral formulation for moderate Oral MAY 2014 phine/oxycodone) Actavis to severe acute pain Bunavail (buprenor- BioDelivery Oral Opioid dependence JUN 2014 phine/naltrexone) Contrave (naltrexone/ Orexigen, Takeda Oral Obesity JUN 2014 ER) Zerenex (ferric citrate Hyperphosphatemia in Keryx, Panacor Oral JUN 2014 coordination compex) end-stage renal disease Lecette (desogestrel/ Teva Oral Prevention of pregnancy JUL 2014 ethinyl estradiol) 14

TBA (indomethacin Iroko Oral Pain JUL 2014 submicron) Moderate-to-severe acute Zalviso (sufentanil) AcelRx Sublingual JUL 2014 pain in hospital setting TBA (budesonide) Salix Rectal Mild to moderate ulcerative colitis SEP 2014 Acorda TBA (diazepam) Nasal Seizures, epilepsy SEP 2014 Therapeutics RedHill TBA (rizatriptan) BioPharma, Oral Acute migraine SEP 2014 IntelGenX Alisade GlaxoSmithKline Inhalation Asthma OCT 2014 () Natpara (recombinant human NPS, Takeda SubQ Hypoparathyroidism OCT 2014 ) TBA (liraglutide) Novo Nordisk SubQ Weight management OCT 2014 Rextoro (testosterone Clarus Oral Testosterone deficiency NOV 2014 undecanoate) Therapeutics TBA () Medac SubQ Rheumatoid arthritis & psoriasis NOV 2014 TBA (sumatriptan OptiNose, Avanir Nasal Acute treatment of migraine NOV 2014 intranasal) Rytary (carbidopa/ levo- Impax Oral Parkinson’s disease 2014 dopa ER) TBA (norethindrone transdermal delivery Actavis Topical Prevention of pregnancy 2014 system) Twirla (ethinyl estradi- Agile Therapeu- Transdermal Prevention of pregnancy 2014 ol/levonorgestrel) tics Prevention of nausea & vomiting TBA () RedHill Oral 1Q2014 (filing*) in cancer patients Toctino () Basilea, Stiefel Oral Atopic dermatitis (eczema) 1Q2014 (filing*) Swedish Orphan Orfadin (nitisinone) Oral Hereditary tyrosinemia type 1 1Q2014 (re-filing*) Biovitrum Ventrus, Pain associated with Anoheal (diltiazem) Topical 2Q2014 (filing*) SLA Pharma anal fissure Chemotherapy-induced Sustol (granisetron SR) Heron SubQ 2Q2014 (re-filing*) nausea & vomiting Androxal 3Q – 4Q2014 Repros Oral Secondary hypogonadism (enclomiphene citrate) (filing*) Bema LA Moderate to severe BioDelivery, Endo Oral 4Q2014 (filing*) (buprenorphine buccal) chronic pain TBA (glycopyrronium Novartis Inhalation Moderate to severe COPD 4Q2014 (filing*) bromide/indacaterol) TBA (morphine ER) Egalet Oral Moderate to severe pain 4Q2014 (filing*) 4Q2014 – 2Q2015 TBA (progesterone) TherapeuticsMD Oral Secondary amenorrhea (filing) Ameluz (5-aminolevulinic Biofrontera Topical Actinic keratosis 2014 (filing*) acid nanocolloidal) Neuropathic pain associated with chemo- Amiket therapy-induced peripheral neuropathy in EpiCept Topical 2014 (filing*) (ketamine/amitriptyline) patients previously treated with - based chemotherapy Amitiza (lubiprostone) Sucampo, Takeda Oral Chronic idiopathic constipation 2014 (filing*) Asacard Flamel, Secondary prevention of Oral 2014 (filing*) (acetylsalicylic acid) NewHaven cardiovascular disease Pain, swelling, & inflammation Bromsite (bromfenac) InSite Vision Ophthalmic 2014 (filing*) associated with ocular surgery CCP-01 Tris, Vernalis Oral Cough & cold 2014 (filing*) Relistor Opioid-induced constipation (methylnaltrexone Salix SubQ 2014 (filing*) in chronic pain bromide) Seebri Breezhaler (glycopyrronium bromide Vectura, Novartis Inhalation COPD 2014 (filing*) long-acting) TBA ( CR) RedHill Oral Hypertension, heart failure 2014 (filing*) Iron deficiency anemia associated with TBA (ferric trimaltol) Vitra Oral 2014 (filing*) inflammatory bowel disease

15

TBA (hydrocodone/ Mallinckrodt Oral Pain 2014 (filing*) acetaminophen ER) TBA Cephalon, Teva Oral Pain 2014 (filing*) (hydrocodone bitartrate) TBA (hydromorphone KemPharma Oral Pain 2014 (filing*) prodrug) TBA (insulin glargine) Sanofi SubQ Type 1 & type 2 diabetes 2014 (filing*) TBA (insulin peglispro) Eli Lilly SubQ Type 1 and type 2 diabetes 2014 (filing*) TBA (lidocaine/prilocaine) Piethora Topical Premature ejaculation 2014 (filing*) Lightlake TBA (naloxone) Nasal Binge eating disorder 2014 (filing*) Therapeutics TBA (oxycodone ER) Collegium Oral Pain 2014 (filing*) TBA (tadalafil) IntelGenX Oral Erectile dysfunction 2014 (filing*) Vycavert (hydrocodone/ Acura Oral Moderate to severe pain 2014 (filing*) acetaminophen) Viviant (bazedoxifene) Pfizer Oral Postmenopausal osteoporosis 2014 (re-filing*) TBA (cough/ Tris, Vernalis Oral Cough & cold 2014 – 2015 (filing*) cold therapy ER) Pain Therapeutics Remoxy (oxycodone CR) Oral Moderate to severe chronic pain 2015 Direct, Pfize Acute & maintenance therapy of bipolar I APR 2015 – TBA (ramelteon) Takeda Sublingual disorder MAR 2016 (filing*) TBA(estradiol/ TherapeuticsMD Oral Menopause symptoms 4Q2015 (filing*) progesterone) BIOD-Stable Glucagon Hypoglycemia caused by insulin overdose (premixed stable gluca- Biodel SubQ 2015 (filing*) or congenital hyperinsulinism gon) Bydureon ( CR) AstraZeneca SubQ Type 2 diabetes 2015 (filing*) Watson, Gedeon Anemia associated with Esmya (ulipristal acetate) Oral 2015 (filing*) Richter uterine leiomyomas FibroCaps The Medicine not specified Hemostasis 2015 (filing*) (fibrinogen/thrombin) Company SLA Pharma, Incostop (phenylephrine) Rectal Fecal incontinence 2015 (filing*) Ventrus Secondary hyperpara-thyroidism associat- Rayaldy, Replidea Cytochroma Oral ed with vitamin D insufficiency 2015 (filing*) (calcifediol) in patients with CKD TBA (capsaicin) NeurogesX Topical Neuropathic pain 2015 (filing*) Intarcia Thera- TBA (exenatide SR) SubQ Type 2 diabetes 2015 (filing*) peutics TBA (testosterone Lipocine Oral Male hypogonadism 2015 (filing*) undecanoate) Tefina (testosterone) M et P Pharma Nasal Female sexual arousal disorder 2015 (filing*) Vagicap (estradiol) TherapeuticsMD Vaginal Postmenopausal vulvar & vaginal atrophy 2015 – 2016 (filing*) Tresiba () Novo Nordisk SubQ Type 1 & type 2 diabetes 2016 TBA (apomorphine) Cynapsus Sublingual Parkinson’s disease 2016 (filing*) TBA (clonidine) BioDelivery Topical Painful diabetic neuropathy 2016 (filing*) TBA (methylphenidate KemPharma, Oral ADHD 2017 (filing*) prodrug/ligand) Monosol Rx TBA Neos Oral ADHD uncertain (amphetamine polistirex) Therapeutics TBA Santarus Oral Infectious diarrhea uncertain (rifamycin SV MMX) TBA (zucapsaicin/ Winston Topical Osteoarthritis uncertain ciscapsaicin)

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

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Route of Generic Name Brand Name Manufacturer Indication(s) / Use Approval / Administration Market Date glatiramer acetate Copaxone Teva Injection MS MAY 2014 Bristol-Myers efavirenz Sustiva Oral Antiviral MAR 2015 Squibb

16

epinephrine Epipen Mylan Injection Anaphylactic reactions JUN 2015 imatinib Gleevec Novartis Oral Cancer JUL 2015 Targretin Eisai Oral, Topical Cutaneous T-cell lymphoma JUL 2015 / Human immunodeficiency Epzicom GlaxoSmithKline Oral MAR 2016 virus (HIV) infection lamivudine/abacavir/ Trizivir ViiV Healthcare Oral HIV-1 infection MAR 2016 lopinavir/ritonavir Kaletra Abbott Oral Antiviral DEC 2016 Bristol-Myers atazanavir Reyataz Oral Antiretroviral JUL 2017 Squibb tadalafil Adcirca Synthon Oral Pulmonary arterial hypertension NOV 2017 tenofovir Viread Gilead Oral Antiviral JAN 2018 efavirenz/emtricitabine/ Atripla Gilead Oral Antiviral AUG 2018 tenofovir fentanyl Fentora Cephalon Buccal Breakthrough cancer pain OCT 2018

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

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated FDA Route of Filing / Drug Name Manufacturer Indication(s) / Use Administration Approval / Market Date Bristol Myers Diabetes and/or hypertriglyceridemia in Myalept (metreleptin) Squibb, SubQ approved† those with rare forms of lipodystrophy AstraZeneca Otezla (apremilast) Celgene Oral Active psoriatic arthritis approved† Millenium, Moderate to severe active Entyvio (vedolizumab) SubQ; IV APR 2014 Takeda Crohn’s disease, ulcerative colitis MAY – JUN Cerdelga (eliglustat tartrate) Genzyme Oral Gaucher disease type 1 2014 Elonva (corifollitropin alfa) Merck SubQ Infertility JUN – JUL 2014 Esbriet (pirfenidone) InterMune Oral Idiopathic pulmonary fibrosis 3Q2014 Anaplastic lymphoma kinase p TBA (ceritinib) Novartis Oral ositive (ALK+) metastatic 3Q – 4Q 2014 non-small cell lung cancer TBA () Gilead Sciences Oral Relapsed chronic lympocytic leukemia AUG 2014 Boehringer TBA (faldaprevir) Oral Hepatitis C virus infection 4Q2014 Ingelheim Glax- TBA (dolutegravir/ oSmithKline, Oral HIV OCT 2014 lamivudine/abacavir) Viiv, Shionogi TBA (secukinumab) Novartis SubQ; IV Moderate to severe plaque psoriasis OCT 2014 Aeterna Growth hormone deficiency, Solorel (macimorelin acetate) Oral NOV 2014 Zentaris treatment of cachexia TBA (avatrombopag) Eisai Oral Immune thrombocytopenic purpura 1Q2014 (filing*) TBA (lenvatinib mesylate) Eisai Oral Endometrial cancer, thyroid cancer 1Q2014 (filing*) TBA (apremilast) Celgene Oral Psoriatic arthritis 2Q2014 (filing*) TBA (dasabuvir) AbbVie Oral Hepatitis C 2Q2014 (filing*) TBA (ombitasvir) AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) TBA (veruprevir) AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) TBA (veruprevir/ritonavir/ AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) ombitasvir) TBA (veruprevir/ritonavir/ Enanta, AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) ombitsavir/desabuvir) APR 2014 – TBA (alisertib) Takeda Oral Peripheral T-cell lymphoma MAR 2015 (filing*) 3Q-4Q 2014 TBA (apricitabine) Avexa Oral Multidrug resistant HIV infection (filing*) Glaxo- Bosatria (mepolizumab) SubQ Severe uncontrolled refractory asthma 4Q2014 (filing*) SmithKline 4Q2014 – TBA (lomibuvir) Vertex Oral Hepatitis C virus infection 1Q2015 (filing*) Cinquil (reslizumab) UCB SubQ Eosinophilic asthma 2014 (filing*) Faridak () Novartis Oral Multiple myeloma 2014 (filing*) TBA (acolbifene) Endoceutics Oral Breast Cancer 2014 (filing*)

17

Bristol Myers TBA (asunaprevir) Oral Hepatitis C 2014 (filing*) Squibb In combination with Zelboraf TBA (cobimetinib) Genentech Oral 2014 (filing*) for metastatic melanoma Bristol Myers TBA (daclatasvir) Oral Hepatitis C virus infection 2014 (filing*) Squibb Bristol Myers TBA (daclatasvir/asunaprevi) Oral Hepatitis C virus infection 2014 (filing*) Squibb TBA (danoprevir) Roche Oral Hepatitis C virus infection 2014 (filing*) TBA (eteplirsen) AVI BioPharma -- Duschenne muscular dystrophy 2014 (filing*) Cystic fibrosis homozygous for TBA (lumacaftor) Vertex Oral 2014 (filing*) F508del CFTR mutation Cystic fibrosis homozygous for TBA (lumacaftor/ivacaftor) Vertex Oral 2014 (filing*) F508del CFTR mutation Pharmasset, TBA (mericitabine) Oral Hepatitis C virus infection 2014 (filing*) Roche Amicus Thera- TBA (migalastat) peutics, Glaxo- Oral Fabry disease 2014 (filing*) SmithKline TBA (sonidegib/erismodegib) Novartis Oral Advanced basal cell carcinoma 2014 (filing*) ACT Biotech, TBA (telatinib) Oral Gastric cancer 2014 (filing*) Bayer Tybost (cobicistat) Gilead Oral HIV-1 infection 2014 (re-filing*) Vitekta (elvitegravir) Gilead Sciences Oral HIV-1 infection 2014 (re-filing*) TBA (tildrakizumab) Merck SubQ Psoriasis >2014 (filing*) 2014 -2015 FSH-GEX, GT-GP 2.4 GEX Glycotype SubQ Infertility (filing*) Boehringer 2014 – 2015 TBA (deleobuvir) Oral Hepatitis C virus infection Ingelheim (filing*) Eleison,Thresh- 2014 – 2015 TBA (glufosfamide) old Pharma- IV Pancreatic cancer (filing*) ceuticals 2014 – 2015 TBA (momelotinib) Gilead Sciences Oral Myelofibrosis (filing*) Firdapse Catalyst Oral Lambert-Eaton myasthenic syndrome 1Q2015 (filing*) (amifampridine phosphate) CO-1686 Clovis, Celgene Oral Non-small cell lung cancer 4Q2015 (filing*) Acute myeloid leukemia, Rydapt (midostaurin) Novartis Oral 2015 (filing*) aggressive systemic mastocytosis Bristol Myers TBA (beclabuvir) Oral Hepatitis C virus infection 2015 (filing*) Squibb Amgen, Astra- TBA (brodalumab) SubQ Moderate to severe plaque psoriasis 2015 (filing*) Zeneca TBA (buparlisib) Novartis Oral Breast cancer 2015 (filing*) TBA (ledipasvir) Gilead Sciences Oral Hepatitis C virus infection 2015 (filing*) Cell Therapeu- TBA (pacritinib) Oral Myelofibrosis 2015 (filing*) tics Sanofi Aventis, Rheumatoid arthritis, TBA (sarilumab) SubQ 2015 (filing*) Regeneron ankylosing spondylitis Active Biotech, TBA (tasquinimod) Oral Metastatic castrate-resistant prostate cancer 2015 (filing*) Ipsen Taiho Pharma- TBA (trifluridine/tipiracil) Oral Metastatic colorectal cancer 2015 (filing*) ceutical 2015 – 2016 TBA (gevokizumab) Xoma SubQ Pyoderma gangrenosum (filing*) Bone loss disorders, 2015-2016 TBA (romosozumab) UCB, Amgen SubQ including postmenopausal (filing*) osteoporosis and bone fractures LCI-699 Novartis Oral Cushing’s disease 2016 (filing*) TBA (benralizumab) AstraZeneca SubQ Severe uncontrolled asthma 2016 (filing*) TBA (binimetinib) Novartis Oral NRAS melanoma 2016 (filing*) TBA Novartis Oral BRAF mutant melanoma 2016 (filing*) (binimetinib/encorafenib) Hyperlipidemia, dyslipidemia, & heterozy- TBA (bococizumab) Pfizer SubQ 2016 (filing*) gous familial hypercholesterolemia TBA (dovitinib) Novartis Oral Renal cell cancer 2016 (filing*) TBA (encorafenib) Novartis Oral BRAF mutant melanoma 2016 (filing*) TBA (lebrikizumab) Genentech SubQ Asthma 2016 (filing*)

18

TBA () AstraZeneca Oral BRCA-mutated ovarian cancer 2016 (filing*) TBA (setrobuvir) Roche Oral Hepatitis C virus infection 2016 (filing*) TBA (guselkumab) Janssen SubQ Psoriasis, rheumatoid arthritis 2017 (filing*) TBA (selumetinib) AstraZeneca Oral KRAS+ non-small cell lung cancer 2017 (filing*) TBA (sirukumab) Janssen SubQ Rheumatoid arthritis 2017 (filing*) BGJ-398 Novartis Oral Solid tumors >2017 (filing*) BYL-719 Novartis Oral Solid tumors >2017 (filing*) TBA (alisporivir) Novartis Oral Hepatitis C virus infection >2017 (filing*) TBA (dactolisib) Novartis Oral Solid tumors >2017 (filing*) TBA (quilizumab) Novartis SubQ Allergic diseases >2017 (filing*) TBA (siponimod) Novartis Oral Secondary progressive MS >2017 (filing*)

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

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated FDA Route of Filing / Drug Name Manufacturer Indication(s) / Use Administration Approval / Market Date Lonquex (lipegfilgrastim) Teva SubQ Chemotherapy-induced neutropenia 1Q2014 Concentrated formulation for Kalbitor (ecallantide) Dyax SubQ MAR 2014 hereditary angioedema Hyqvia (immunoglobulin Baxter, Primary immunodeficiency [human]/hyaluronidase [hu- SubQ JUN 2014 Halozyme in adults man, recombinant]) Plegridy Biogen Idec SubQ Relapsing forms of MS AUG 2014 (peginterferon beta-1a) Nova, Rare Dis- Xaluprine () ease Therapeu- Oral Acute lymphoblastic leukemia 4Q2014 tics Improved tablet formulation for kidney Envarsus (tacrolimus) Veloxis Oral OCT 2014 transplant rejection prevention TBA (sofosbuvir/ledipasvir) Gilead Oral Hepatitis C virus infection OCT 2014 TBA (treprostinil United Thera- Oral Pulmonary arterial hypertension 2014 diethanolamine) peutics Biogen Idec, TBA (daclizumab) SubQ Relapsing remitting MS 4Q2014 (filing*) AbbVie Gram-negative lung infections caused by Insmed, pseudomonas aeruginosa in patients with Arikace (amikacin liposomal) Inhalation 2014 (filing*) Transave cystic fibrosis & bronchiectasis, non- tuberculous mycobacteria lung infections Octreolin (ocreotide acetate) Chiasma, Roche Oral Acromegaly 2014 (filing*) TBA (caplacizumab) Ablynx SubQ Thrombotic thrombocytopenic purpura 2014 (filing*) Phenylase BioMarin SubQ Phenylketonuria 1Q2015 (filing*) (phenylalanine hydroxylase) TBA (tenofovir alafenamide) Gilead Sciences Oral HIV-1 infection in treatment-naïve adults 1Q2015 (filing*) BA-058, BIM-44058, Redium Health, SubQ Postmenopausal osteoporosis 2015 (filing*) ITM-058 Teijin Signifor LAR (pasireotide) Novartis SubQ Cushing’s syndrome 2015 (filing*) TBA (growth hormone) Prolor Biotech SubQ Growth hormone deficiency 2015 (filing*) TBA Bristol Myers Hepatitis B virus infection, SubQ 2015 (filing*) (peginterferon lambda-1a) Squibb hepatitis C virus infection

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