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April through June 2014 Updated Warnings—Current Drugs Public Notification Regarding Male Sexual Enhancement Products: The FDA is advising consumers not to purchase or use GoldReallas, Full Throttle On Demand, 3 Hard Knights, Dick’s Hard Up, Eyeful, Liu Bian Li, products promoted and sold for sexual enhancement on various websites and in some retail stores. FDA laboratory analysis confirmed that these products contained the following undeclared drug ingredients: • GoldReallas: sildenafil and thiosildenafil • Full Throttle On Demand: propoxyphenyl sildenafil • 3 Hard Knights: sildenafil and thiosildenafil • Dick’s Hard Up: tadalafil • Eyeful: hydroxythiohomosildenafil • Liu Bian Li: sildenafil These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Sildenafil is the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction (ED). The other undeclared ingredients are structurally similar to sildenafil. Consumers should stop using these products immediately and throw them away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. (6/3/14) Asset Bold: Undeclared Drug Ingredient: The FDA is advising consumers not to purchase or use Asset Bold, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that Asset Bold contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking. Asset Bold is a product promoted and sold for weight loss on various websites and in some retail stores. The FDA is recommending that consumers do not purchase or use Asset Bold. (5/16/14) Undeclared Drug Ingredient Found in MV5 Days: The FDA is advising consumers not to purchase or use MV5 Days, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that MV5 Days contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra, used to treat ED. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. MV5 Days is a product promoted and sold for sexual enhancement on various websites and in some retail stores. FDA is recommending that consumers do not purchase or use MV5 Days. (5/16/14) Lunesta—Next Day Impairments: The FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. FDA approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes. A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose. Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them. FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-thecounter drugs available without a prescription, and will update the public as new information becomes available. (5/15/14) www.AmericanHealthCare.com For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 1 Pradaxa Study by FDA: Increased Risk of GI Bleeding: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs. Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use. Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF). Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death. Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label. (5/13/14) Asset Bee Pollen—Undeclared Drug Ingredient: The FDA is advising consumers not to purchase or use Asset Bee Pollen, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that Asset Bee Pollen contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in lifethreatening ways, with other medications a consumer may be taking. Asset Bee Pollen is a product promoted and sold for weight loss on various websites. The FDA is recommending patients not purchase or use Asset Bee Pollen. (5/12/14) Natural Body Solution—Undeclared Drug Ingredient: The FDA laboratory analysis confirmed that Natural Body Solution contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking. Natural Body Solution is promoted and sold for weight loss and sold on various websites and in some retail stores. FDA is advising consumers not to purchase or use Natural Body Solution. (5/6/14) Slim Trim U: Undeclared Drug Ingredient Found: The FDA laboratory analysis confirmed that Slim Trim U contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in lifethreatening ways, with other medications a consumer may be taking. Slim Trim U is promoted and sold for weight loss and sold on various websites and in some retail stores. FDA is advising consumers not to purchase or use Slim Trim U. (5/6/14) GenStrip Blood Glucose Test Strip—Safety Risk: The FDA is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini). Discontinue use of GenStrip Blood Glucose Test Strips. FDA recommends the use of alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters. (4/29/14) FDA Finds Undeclared Drug Ingredients in S.W.A.G: The FDA is advising consumers not to purchase or use S.W.A.G, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that S.W.A.G contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra, used to treat ED. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. S.W.A.G. is promoted and sold on various websites and in some retail stores. For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 2 Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. (4/18/14) Zi Xiu Tang Bee Pollen Capsules Warning form FDA: The FDA is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label. The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States. All products that have been tested, including those that claim to be “genuine” and “anti-counterfeit,” have been found to contain one or both of the following undeclared drug ingredients: • Sibutramine – a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. • Phenolphthalein – a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk. The FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Reports have included heart palpitations, tachycardia (increased heart rate), suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have experienced any negative side effects while taking this product should consult a health care professional. Zi Xiu Tang Bee Pollen is manufactured by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd. in Guangdong Province, China. It is offered for sale on the Internet, and it can be found in various retail stores, spas and fitness centers. In addition, licensed health care professionals have promoted the product. The FDA is investigating the distribution of Zi Xiu Tang Bee Pollen products in the United States and may issue warning letters or take enforcement action, such as seizures, injunctions and/or criminal charges. (4/8/14) Revatio Pediatric Use Warning: The FDA is clarifying its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is FDA-approved only to treat PAH in adults, not in children; however, health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient. FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with PAH. FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring. The purpose of the August 2012 recommendation was to raise awareness of clinical trial results showing a higher risk of mortality in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose. This recommendation was not intended to suggest that Revatio should never be used in children; however, some health care professionals have interpreted this information as a contraindication, and have refused to prescribe or administer the drug. The evidence behind FDAs initial recommendation has not changed; this communication is clarifying the strength of the warning communicated in the Revatio drug label. (3/31/14) Recalls/Suspensions 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 information located at the end of the bulletin). African Black Ant, Black Ant, and Mojo Risen Products: Eugene Oregon, Inc. is voluntarily conducting this recall because FDA analysis of these products distributed to a third party revealed that the distributed products contained undeclared amounts of the active pharmaceutical ingredients sildenafil and tadalafil—FDA-approved pharmaceutical ingredients used to treat ED. Conclusive testing has not been done to confirm that the recalled products do, in fact, contain sildenafil and/or tadalafil and this recall is being executed as a precautionary measure. Sildenafil and tadalafil can pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. Nitrates are found in prescription drugs used to treat diabetes, high blood pressure, high cholesterol, and heart disease. Sildenafil and tadalafil can also cause side effects such as headaches and flushing. Eugene Oregon, Inc. has discontinued the distribution of these products and is notifying its distributors by mail of this voluntary recall. Consumers that possess these products should stop using them immediately and can return the products to Eugene Oregon, Inc., 922 S. Woodbourne Rd. #304, Levittown, PA 19057-1001. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products. Consumers with questions regarding this recall can contact Eugene Oregon, Inc. by telephone at 1-800-538-3411 from Monday through Friday between 9:00 a.m. and 5:00 p.m. EST. (5/6/14) Nova Products, Inc.—Dietary Supplements: Nova Products, Inc. issued a voluntary recall of the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 3 ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012) at the retail level. The FDA laboratory analysis on these products has determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat ED. These undeclared active ingredients pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. Prescription drugs containing nitrates are frequently prescribed for individuals with diabetes, high blood pressure, high cholesterol, or heart disease. Additionally, these products may cause side effects such as headaches and flushing. These products are marketed as dietary supplements for sexual enhancement and packaged in blister packs, envelopes, bottles, and/or boxes distributed to consumers nationwide at retail stores. Lot numbers are identified on the back or side of each product. Consumers that possess these products should stop using them immediately and return the products to Nova Products, Inc., 5 Mount Pleasant Road, Aston, Pennsylvania. Consumers with questions regarding this recall can contact Nova Products, Inc. by telephone at 610-459-7709 between 9:00 a.m. and 5:00 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products. (3/31/14) Bella Vi Brand Products by Pure Edge Nutrition: Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up, to the consumer level. The FDA laboratory analyses found the products to contain undeclared sibutramine or a combination of both sibutramine and phenolphthalein. Sibutramine was removed from the US market in October 2010 for safety reasons and phenophthalein is used as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs. Products containing sibutramine and phenophthalein pose a threat to consumers because sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. All affected products are marketed as dietary supplements for weight loss. Pure Edge Nutrition, LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using and return products to Pure Edge Nutrition, LLC. Consumers with questions regarding this recall can contact Pure Edge Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00 a.m. – 2:00 p.m. EST or email info@pureedgenutrition. com. (3/26/14) New Life Nutritional Dietary Supplements: New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein, or a combination of both sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmias, and strokes). Phenolphthalein is an ingredient previously used in overthe-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products are used as weight loss aids and are packaged in 30 capsule bottles. New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website at www.newlifenutritional.com. New Life Nutritional Center is notifying its customers by letter. Customers are advised to immediately discontinue use of these products and should return the products immediately to New Life Nutritional Center 714 West 181st Street NY, NY 10033 for a refund. (3/26/14) Approved Drugs Please access www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm for in-depth drug approval information. Sivextro Approved by FDA to Treat Skin Infections: The FDA today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is available for intravenous and oral use. Sivextro is the second new antibacterial drug approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved Dalvance (dalbavancin), also to treat patients with ABSSSI caused by Staphylococcus aureus and various Streptococcus species. Sivextro’s safety and efficacy were evaluated in two clinical trials with 1,315 adults with ABSSSI. Participants were randomly assigned to receive Sivextro or linezolid, another antibacterial drug approved to treat ABSSSI. Results showed Sivextro was as effective as linezolid for the treatment of ABSSSI. The most common side effects identified in the clinical trials were nausea, headache, diarrhea, vomiting and dizziness. The safety and efficacy of Sivextro have not been evaluated in patients with decreased levels of white blood cells (neutropenia), so alternative therapies should be considered. Sivextro is marketed by Cubist Pharmaceuticals, based in Lexington, Massachusetts. (6/23/14) For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 4 Zontivity: The FDA approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs. Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It is an antiplatelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke. Like other drugs that inhibit blood clotting, Zontivity increases the risk of bleeding, including life-threatening and fatal bleeding. Bleeding is the most commonly reported adverse reaction in people taking Zontivity. The drug’s prescribing information (label) includes a Boxed Warning to alert health care professionals about this risk. Zontivity must not be used in people who have had a stroke, transient ischemic attack, or bleeding in the head, because the risk of bleeding in the head is too great. Patients should report to their health care professional any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine. Zontivity will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Zontivity is made by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. of Whitehouse Station, N.J. (5/8/14) Epanova: Epanova, generic name omega-3-carboxylic acids, has been approved by the FDA. Epanova is indicated as an adjunct to diet to treat severe hypertriglyceridemia in adult patients. Severe hypertriglyceridemia is defined as triglyceride levels of greater than or equal to 500mg/dL. Epanova is manufactured by AstraZeneca and is available in capsule form. (5/7/14) Incruse Ellipta: The FDA has approved GlaxoSmithKline’s Incruse Ellipta (umeclidinium) once-daily inhalation powder for the treatment of long-term maintenance of airflow obstruction in patients diagnosed with chronic obstructive pulmonary disease (COPD); also including chronic bronchitis and/or emphysema. GlaxoSmithKline anticipates a fourth quarter 2014 launch of Incruse Ellipta. (5/1/14) Cyramza for Stomach Cancer: The FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. Stomach cancer forms in the tissues lining the stomach and mostly affects older adults. According to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year. Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy. Common side effects experienced by Cyramza-treated participants during clinical testing include diarrhea and high blood pressure. The FDA reviewed Cyramza under its priority review program, which provides an expedited review for drugs that have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition. Cyramza is marketed by Indianapolis-based Eli Lilly. (4/22/14) Ragwitek for Short Ragweed Pollen Allergies: The FDA approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age. Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home. Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots. The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life-threatening, can occur. Ragwitek also has a Medication Guide for distribution to the patient. Ragwitek is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom. (4/18/14) Tanzeum Injection: The FDA today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 5 or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise. Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC). The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum. (4/16/14) Otezla: The FDA approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA). PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness, and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin23 inhibitor. The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure. In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache. Otezla is manufactured for Celgene Corporation, Summit, N.J. (3/21/14) New Generics Generic Celebrex Approved: The FDA approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, shortterm (acute) pain, and other conditions. Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram (mg), 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules. Celecoxib is a non-steroidal anti-inflammatory drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential lifethreatening GI bleeding that has been associated with use of NSAIDs. (5/30/14) FDA Approves Generic Vesicare: The FDA approved the generic equivalent of Vesicare, solifenacin succinate, used for the treatment of overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence. Solifenacin succinate is manufactured by Teva Pharmaceuticals and is available as a 5mg and 10mg tablet. (4/20/14) Generic Lunesta Approved: Mylan Inc. today announced that it has launched Eszopiclone Tablets 1 mg, 2 mg and 3 mg, the generic version of Sunovion Pharmaceuticals Inc.'s Lunesta. Mylan received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of insomnia. (4/16/14) Approval of Generic Lovaza by Teva: Teva Pharmaceutical Industries Ltd. announced the approval of the generic equivalent to Lovaza (omega-3-acid ethyl esters capsules, USP), in the United States. Omega-3-acid ethyl esters is available as 1 gram oral capsules containing at least 900mg of the ethyl esters of omega-3 fatty acids. Omega3-acid ethyl esters are used as adjunct to diet therapy in the treatment of hypertriglyceridemia (triglycerides ≥ 500 mg/dL). Teva plans to commence shipping immediately. (4/10/14) Generic Mepron Suspension Approval: The generic of brand name Mepron, atovaquone, was approved by the FDA for patients intolerant to trimethoprimsulfamethoxazole (TMP-SMZ) to prevent pneumocystis carinii pneumonia (PCP). This drug is also approved in patients intolerant to TMP-SMZ for short-term oral treatment of mild to moderate PCP. Atovaquone is manufactured by Amneal Pharmaceuticals and is available as a 750mg/5mL oral suspension. (3/24/14) New Indications Reyataz—Expanded Indication and New Dosage Form: The FDA has approved an expanded indication for Reyataz (atazanavir) to include pediatric patients at least 3 months of age who weigh at least 10 kg for the treatment of HIV-1 infection in combination with other antiretroviral agents. Previously, Reyataz was only indicated for the treatment of adults and pediatrics at least 6 years of age. Additionally, the FDA has approved a new oral powder dosage form for use in treatment-naive or treatmentexperienced pediatric patients who are at least 3 months of age and weigh between 10 kg and less than 25 kg. (6/4/14) Expanded Indication for Arzerra: The FDA has approved an expanded indication for GlaxoSmithKline’s Arzerra (ofatumumab). This expanded indication now includes the treatment of previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil in those who are unable to take fludarabine. Arzerra is also indicated for the treatment of those with CLL refractory to fludarabine and alemtuzumab. (4/22/14) For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 6 Expanded Indication for Pradaxa: The FDA has approved an expanded indication for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) capsules to include the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with an injectable anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. Pradaxa is also indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Pradaxa labeling now also includes an updated Boxed Warning regarding the risk of spinal/epidural hematoma in patients receiving neuraxial anesthesia or undergoing spinal puncture, in addition to the existing warning that premature discontinuation increases the risk of thrombotic events. Pradaxa is dispensed with a patient Medication Guide. (4/8/14) Kalbitor Expanded Indication: The FDA has approved an expanded indication for Dyax’s Kalbitor (ecallantide) to include the treatment of acute attacks of hereditary angioedema in patients 12 years of age and older. Kalbitor was previously approved for treatment in patients16 years of age and older. The prescribing information for Kalbitor includes a Boxed Warning regarding the risk of anaphylaxis and it is dispensed with a patient Medication Guide. (4/7/14) Indication for Baraclude Expanded by the FDA: Baraclude, known generically as entecavir, has been approved by the FDA for use in children who have the chronic hepatitis B virus with active viral replication and evidence of either persistent elevations in serum aminotransferases or histologically active disease. Use in children is approved for those who are two years or older. Previously, this medication was only approved for use in adult patients. Baraclude is manufactured by Bristol-Myers Squibb. (3/26/14) FDA Expands Xolair Indication: Xolair (omalizumab) injection is now approved by the FDA to treat patients 12 years and older with chronic idiopathic urticaria who still experience symptoms despite H1 antihistamine treatment. This drug is also approved to treat moderate to severe persistent asthma in patients 12 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who still experience symptoms due to inadequate control with inhaled corticosteroids. Xolair’s label does contain a boxed warning stating the risk of anaphylaxis after administration. (3/24/14) Miscellaneous Nexium 24HR Approved for OTC: The FDA approved over-the-counter Nexium® 24HR (esomeprazole 20mg). In 2012, Pfizer acquired exclusive global rights from AstraZeneca to market non-prescription Nexium®. Pfizer continue to work closely with AstraZeneca and retail partners to make Nexium® 24HR available to consumers in the U.S., with other markets in Europe expected to follow this year. (3/28/14) 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, dietary 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. Revised Labeling/ Prescribing Information Synera for Home Use: The FDA has approved a label change that will allow patients to use Synera (lidocaine and tetracaine) topical patch at home. Galan US’s Synera patch is indicated for use in patients 3 years and older on intact skin to provide local analgesia for superficial venous access and superficial dermatological procedures. (6/4/14) For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 7 NON-SPECIALTY Non-Specialty Generic Drugs Pipeline † indicates the medication has been approved but may or may not be available * indicates the medication is anticipated to be filed with the FDA at the listed date Brand Name Brand Manufacturer Route of Administration Indication(s) / Use Estimated Approval / Market Date Alocril Allergan Ophthalmic Allergies approved† Avandamet GlaxoSmithKline Oral Type 2 diabetes approved† Avandia Celebrex GlaxoSmithKline Pfizer Oral Oral Type 2 diabetes Osteoarthritis, pain approved† approved† Dibenzyline Roxane Oral Pheochromocytoma approved† lamotrigine ODT Lamictal ODT Actavis Oral Seizures approved† pregabalin Lyrica Pfizer Oral Diabetic peripheral neuropathy, postherpetic neuralgia, seizures, fibromyalgia approved† Shionogi Pharma Oral Asthma, atopic dermatitis, allergic rhinitis approved† Roche Oral Cytomegalovirus approved† Nasonex Schering Nasal Allergies JUL 2014 Lumigan Allergan Ophthalmic Glaucoma, ocular hypertension AUG 2014 Renagel Genzyme Oral chronic kidney disease (CKD) SEP 2014 Exforge Novartis Oral High blood pressure OCT 2014 Exforge HCT Novartis Oral High blood pressure OCT 2014 Intuniv Actavis Oral Advicor Asacol Diovan Abbott Warner Chilcott Novartis Oral Oral Oral Attention deficit hyperactivity disorder (ADHD) Cholesterol Ulcerative colitis, proctitis High blood pressure Fosrenol Shire Oral Hyperphosphatemia associated with CKD 2014 Invega Loestrin 24 Fe Nexium Oxycontin Restasis Janssen Oral Schizophrenia 2014 Warner Chilcott Oral Birth control pill 2014 AstraZeneca Purdue Allergan Oral Oral Ophthalmic Gastroesophageal reflux disease, ulcers Moderate to severe pain Chronic dry eye 2014 2014 2014 Viracept ViiV Healthcare Oral Antiretroviral 2014 Vivelle-Dot Novartis Transdermal Symptoms of menopause 2014 Tarka Abbott Oral High blood pressure FEB 2015 Welchol Abilify Daiichi Sankyo Otsuka Oral Oral MAR 2015 APR 2015 aprepitant Emend Merck Oral oxybutynin linezolid ciprofloxacin/ hydrocortisone gemifloxacin aspirin/ dipyridamole memantine tablet Oxytrol Zyvox Watson Pfizer Transdermal Oral Cholesterol Psychiatric conditions Chemo-associated nausea & vomiting, prevention of post-op nausea & vomiting Overactive bladder Bacterial infections Cipro-HC Bayer Otic Bacterial ear infections JUN 2015 Factive Cornerstone Boehringer Ingelheim Forest Oral Antibiotic JUN 2015 Oral Stroke prevention JUL 2015 Oral Alzheimer’s disease JUL 2015 Solvay Topical Hormone replacement AUG 2015 Transdermal ADHD SEP 2015 Oral Benign prostatic hyperplasia 4Q2015 Generic Name nedocromil metformin/ rosiglitazone rosiglitazone celecoxib phenoxybenzamine prednisolone valganciclovir mometasone furoate bimatoprost sevelamer hydrochloride amlodipine/ valsartan amlodipine/ valsartan/HCTZ guanfacine ER tablets lovastatin/niacin mesalamine valsartan lanthanum carbonate paliperidone ER ethinyl estradiol/ norethindrone esomeprazole oxycodone ER cyclosporine nelfinavir mesylate estradiol transdermal patch trandolapril/ verapamil colesevelam tablet aripiprazole testosterone Orapred ODT Valcyte Aggrenox Namenda Androgel 1% methylphenidate Daytrana dutasteride Avodart Noven Pharmaceuticals GlaxoSmithKline DEC 2014 2014 2014 2014 APR 2015 APR 2015 MAY 2015 8 dutasteride/ tamsulosin mesalamine DR Jalyn GlaxoSmithKline Oral Benign prostatic hypertrophy 4Q2015 Asacol HD Oral Ulcerative colitis NOV 2015 almotriptan Axert Oral Migraine NOV 2015 Oral Migraine NOV 2015 Ortho TriCyclen Lo Patanol Warner Chilcott Ortho-McNeilJanssen Endo Pharmaceuticals Ortho Mcneil Janssen Alcon Oral Birth control pill DEC 2015 Ophthalmic Allergic conjunctivitis DEC 2015 Glumetza Santarus Oral Type 2 diabetes FEB 2016 Enablex Crestor Nuvigil Novartis AstraZeneca Teva Oral Oral Oral Overactive bladder Cholesterol Sleep disorders MAR 2016 MAY 2016 JUN 2016 Ziana Medicis Topical Acne JUL 2016 GlaxoSmithKline Inhalation Asthma, chronic obstructive pulmonary disease (COPD) AUG 2016 GlaxoSmithKline Inhalation Asthma, COPD AUG 2016 Lupin, Mylan Gilead Sciences Oral Oral Rosacea Influenza AUG 2016 AUG 2016 Azor Daiich Sankyo Oral High blood pressure OCT 2016 Benicar Benicar HCT Seroquel XR Relpax Sensipar Zetia Azilect Daiichi Sankyo Oral High blood pressure OCT 2016 Daiichi Sankyo Oral High blood pressure OCT 2016 AstraZeneca Oral Antipsychotic NOV 2016 Pfizer Amgen Merck Teva Oral Oral Oral Oral Migraines Hyperparathyroidism, hypercalcemia Cholesterol Parkinson’s disease DEC 2016 DEC 2016 DEC 2016 FEB 2017 frovatriptan succinate norgestimate/ ethinyl estradiol olopatadine metformin hydrochloride ER darifenacin rosuvastatin armodafinil clindamycin/ tretinoin fluticasone/ salmeterol fluticasone doxycycline oseltamivir olmesartan/ amlodipine olmesartan olmesartan/HCTZ Frova Advair Diskus Flovent Diskus Oracea Tamiflu quetiapine ER tablet eletriptan cinacalcet tablet ezetimibe rasagiline ezetimibe/ simvastatin atomoxetine tiagabine Vytorin Merck Oral Cholesterol APR 2017 Strattera Gabitril Oral Oral ADHD Epilepsy MAY 2017 JUN 2017 sildenafil Viagra Oral Erectile dysfunction DEC 2017 vardenafil testosterone gel rosiglitazone/ glimepiride rivastigmine solution alendronate/ cholecalciferol Levitra Fortesta Lilly Cephalon Actavis, Amneal, Apotex, Dr. Reddy’s, Hetero, Macleods, Mylan, Teva, Torrent Teva Actavis Oral Topical Erectile dysfunction Male hypogonadism OCT 2018 NOV 2018 Avandaryl GlaxoSmithKline Oral Type 2 diabetes uncertain Exelon Novartis Oral Alzheimer’s disease, Parkinson’s disease uncertain Fosamax Plus D Merck Oral Osteoporosis uncertain 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 Drug Name Manufacturer Impavido (miltefosine) Incruse Ellipta (umeclidinium) Jublia (efinaconazole) Paladin Glaxo SmithKline Kaken, Valeant Chelsea Therapeutics Northera (droxidopa) Sivextro (tedizolid phosphate) Trius Route of Administration Indication(s) / Use Estimated FDA Filing / Approval / Market Date Oral Treatment of leishmaniasis approved† Inhalation Asthma, COPD approved† Topical Distal lateral subungal onychomycosis approved† Oral Neurogenic orthostatic hypotension approved† Oral Acute bacterial skin infections, skin structure infections approved† 9 Zontivity (vorapaxar sulfate) TBA (cariprazine) Merck Forest, Gedeon Richter Oral Oral Myocardial infarction Schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder Hypoactive sexual desire disorder in premenopausal women approved† 2Q – 3Q2014 Girosa (filbanserin) Sprout Oral Striverdi Respimat (olodaterol) Targiniq ER (oxycodone/naltrexone) Boehringer Ingelheim Inhalation COPD 3Q2014 Purdue Oral Management of chronic pain 3Q2014 Boehringer Ingelheim, Eli Lilly Oral Type 2 diabetes 3Q2014 Helsinn, Eisai Oral Chemotherapy-induced nausea & vomiting 3Q – 4Q2014 Anacor Merck Topical Oral Oncyhomycosis Insomnia JUL 2014 AUG 2014 Janssen Oral Type 2 diabetes AUG 2014 Oral Opioid-induced constipation SEP 2014 SubQ Type 2 diabetes SEP – OCT 2014 Oral Type 2 diabetes 4Q2014 Valeant Topical Acne NOV 2014 Forest Glaxo SmithKline Oral Hypertension DEC 2014 SubQ Type 2 diabetes 2014 TBA (empagliflozin) TBA (palonosetron/netupitant) TBA (tavaborole) TBA (suvorexant) Vokanamet (canagliflozin/metformin) Movantik (naloxegol) Trulicity (dulaglutide) Xigduo (dapagliflozin/metformin) Onexton (clindamycin/ benzoyl peroxide) TBA (nebivolol/valsartan) Eperzan, Syncria (albiglutide) AstraZeneca, Nektar Eli Lilly AstraZeneca, Bristol Myers Squibb 3Q2014 Lixar (lixivaptan) Cornerstone Oral TBA (omeprazole/aspirin DR) Pozen Oral AL-60371 Alcon Otic TBA (ivabradine) TBA (olodaterol/ tiotropium bromide) Toctino (alitretinoin) TBA (eluxadoline dihydrochloride) TBA (patiromer) Amgen Boehringer Ingelheim Basilea, Stiefel Oral Hyponatremia associated with heart failure, syndrome of inappropriate antidiuretic hormone Prevention of cardio- and cerebro-vascular events, reduce risk of gastric ulcers in patients at risk of aspirin-induced gastric ulcers Otitis externa and media with a tympanostomy tube Chronic heart failure Inhalation COPD 2Q2014 (filing*) Oral 2Q2014 (filing*) Furiex Oral Relypsa AstraZeneca, Bristol Myers Squibb Forest, Almirall Melinta Boehringer Ingelheim, Eli Lilly Ardea Biosciences, AstraZeneca Boehringer Ingelheim, Eli Lilly Acadia, Biovail Oral Atopic dermatitis (eczema) Diarrhea-predominant irritable bowel syndrome Hyperkalemia in patients with CKD Oral Type 2 diabetes 4Q2014 (filing*) Inhalation COPD 4Q2014 (filing*) Oral Uncomplicated gonorrhea 4Q2014 (filing*) Oral Type 2 diabetes 4Q2014 (filing*) Oral Hyperuricemia, gout 4Q2014 (filing*) Oral Type 2 diabetes 4Q2014 (filing*) Oral Parkinson’s disease psychosis 4Q2014 (filing*) Novartis Oral Heart failure 4Q2014 (filing*) Starpharma Vaginal Bacterial vaginosis Osiris Topical Diabetic foot ulcers Hatchtech Cerecor Topical Oral Head lice Cough 4Q2014 (filing*) 4Q2014 – 2015 (filing*) 2014 (filing*) 2014 (filing*) Saxadapa (saxagliptin/dapagliflozin) TBA (aclidinium bromide/formoterol) TBA (delafloxacin) TBA (empagliflozin/metformin IR) TBA (lesinurad) TBA (linagliptin/ metformin ER) TBA (pimavanserin) TBA (sacubitril/valsartan trisodium hemipentahydrate) Vivagel (astodrimer) Grafix (cellular matrix [wound healing]) Deovo (head lice treatment) FP-01 2014 2014 2Q2014 (filing*) 2Q2014 (filing*) 3Q2014 (filing*) 3Q2014 (filing*) 10 Ionsys (fentanyl) The Medicines Company Daiichi Sankyo Scioderm Orexo Helsinn Therapeutics Alexion Otsuka, Lundbeck Amgen Transdermal Acute postoperative pain 2014 (filing*) Oral Topical Sublingual 2014 (filing*) 2014 (filing*) 2014 (filing*) SubQ Stroke prevention in atrial fibrillation Epidermolysis bullosa Pain Treatment of cachexia & anorexia in cancer patients Hypophosphotasia Schizophrenia, adjunctive therapy for major depressive disorder Hypercholesterolemia Charleston Laboratories Oral Pain 2014 (filing*) TBA (nitazoxanide) Romark Oral TBA (odanacatib) TBA (pradigastat) TBA (rifabutin/amoxicillin/ undisclosed PPI) Merck, Celera Novartis Lixiana (edoxaban tosylate) SD-101 TBA (alfentanil) TBA (anamorelin) TBA (asfotase alfa) TBA (brexpiprazole) TBA (evolocumab) TBA (hydrocodone CR/ acetaminophen/ promethazine) Oral SubQ Oral 2014 (filing*) 2014 (filing*) 2014 (filing*) 2014 (filing*) Oral Oral Acute uncomplicated influenza as monotherapy or in combination with oseltamivir Osteoporosis Familial chylomicronemia syndrome 2014 (filing*) 2014 (filing*) RedHill Oral Helicobacter pylori infection 2014 (filing*) TBA (rolapitant) OPKO, Tesaro Oral TBA (uridine triacetate) BTG, Wellstat Oral TBA (omarigliptin) Merck Dainippon Sumitomo Pharma, Eisai Adamas, Forest TBA (ranirestat) Arimenda (memantine/donepezil) Prestalia (perindopril arginine/amlodipine besylate) Symplmed, XOMA 2014 (filing*) Oral Prevention of chemotherapy-induced nausea & vomiting Accidental overexposure to fluorouracil (5FU) due to dosing errors or impaired clearance of 5-FU from the body Type 2 diabetes >2014 (filing*) Oral Diabetic peripheral neuropathy >2014 (filing*) Oral Alzheimer’s dementia JAN 2015 Oral Hypertension JAN 2015 JAN 2015 2014 (filing*) 2014 (filing*) Savaysa (edoxaban tosylate) Daiichi Sankyo Oral Stroke & systemic embolic events risk reduction in non-valvular a-fib, deep vein thrombosis, & prevention of venous thromboembolism TBA (safinamide) Newron, Zambon Oral Parkinson’s disease MAY 2015 Lixilan (insulin glargine/lixisenatide) Sanofi SubQ Type 2 diabetes 4Q2015 Oral Type 2 diabetes 1Q – 2Q2015 (filing*) Topical Diabetic foot ulcers 2Q2015 (filing*) Oral Type 2 diabetes 2Q2015 (filing*) Oral Opioid-induced constipation Takeda Oral Type 2 diabetes Anacor GW Pharmaceuticals Otsuka NovaBay Forest Roche Shire Pearl Therapeutics, AstraZeneca Shire AB Science Novartis Topical Psoriasis, atopic dermatitis 2Q2015 (filing*) APR 2015 – MAR 2016 (filing*) 2015 (filing*) Oral Cancer pain, spasticity in multiple sclerosis (MS) 2015 (filing*) Ophthalmic Oral Oral Oral Adenoviral conjunctivitis Ventricular arrhythmia Schizophrenia Iron overload 2015 (filing*) 2015 (filing*) 2015 (filing*) 2015 (filing*) Inhalation COPD 2015 (filing*) Ophthalmic Oral Oral Dry eye Alzheimer’s disease Fragile X syndrome 2015 (filing*) 2015 (filing*) 2015 (filing*) TBA (empagliflozin/linagliptin) TBA (aclerastide) TBA (empagliflozin/ metformin ER) TBA (bevenopran) TBA (fasiglifam hemihydrates) AN-2728 Sativex (nabiximols) TBA (auriclosene) Stedicor (azimilide) TBA (bitopertin) TBA (deferitazole) TBA (glycopyrronium bromide/formoterol) TBA (lifitegrast) TBA (masitinib) TBA (mavoglurant) Boehringer Ingelheim, Eli Lilly Derma Sciences Boehringer Ingelheim, Eli Lilly Cubist, Eli Lilly 11 TBA (obeticholic acid) TBA (ozenoxacin) TBA (rifabutin/ clarithromycin/clofazimine) TBA (tolperisone CR) TBA (zirconium silicate) Intercept Ferrer Oral Topical Primary biliary cirrhosis Skin & skin structure infections 2015 (filing*) 2015 (filing*) RedHill Oral Crohn’s disease 2015 (filing*) Oral Neuromuscular spasm & spasticity 2015 (filing*) Sanochemia, Katama ZS Pharma Sanofi Aventis, Zealand Titan, Braeburn Oral Hyperkalemia 2015 (filing*) SubQ Type 2 diabetes 2015 (re-filing*) SubQ Opioid dependence in adults 2015 (re-filing*) Merck, ALK-Abello Oral Rhinitis, asthma allergy symptoms caused by house dust mites 2015 – 2016 (filing*) PBT-2 Prana Biotechnology Oral Huntington’s disease TBA (langlenatide) Hanmi SubQ Type 2 diabetes TBA (semaglutide) Novo Nordisk SubQ Type 2 diabetes TBA (anacetrapib) Merck Oral Atherosclerosis, dyslipidemia, hypercholesterolemia 2015 – 2016 (filing*) 2015 – 2016 (filing*) 2015 – 2016 (filing*) 2015 – 2017 (filing*) Novo Nordisk SubQ Type 1 & type 2 diabetes 2016 Teva Oral Huntington’s disease 2016 (filing*) Isis SubQ Dyslipidemia, hypercholesterolemia 2016 (filing*) Reviva NovaBay Oral Topical 2016 (filing*) 2016 (filing*) Portola Oral Schizophrenia Impetigo Stroke prevention in atrial fibrillation patients, prevention of venous thromboembolic events after surgery Oral Levodopa-induced dyskinesia 2016 (filing*) Oral Oral Oral Oral Oral Oral Endometriosis Type 2 diabetes Treatment of migraine Type 2 diabetes Clostridium difficile-associated diarrhea Tardive dyskinesia 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) Oral BPH & Erectile dysfunction 2016 (filing*) Pharnext SAS Oral Charcot-Marie-Tooth disease type 1A 2016 – 2017 (filing*) Novo Nordisk SubQ Type 2 diabetes 1Q2017 (filing*) Novartis Novartis Novartis Novartis Novartis Novartis, Cytos Oral Oral Oral Oral Oral SubQ COPD Obese hypogonadotropic hypogonadism Clostridium difficile infection Type 2 diabetes Asthma Alzheimer’s disease >2017 (filing*) >2017 (filing*) >2017 (filing*) >2017 (filing*) >2017 (filing*) >2017 (filing*) Novartis Inhalation Asthma, COPD >2017 (filing*) Lyxumia (lixisenatide) Probuphine (buprenorphine) Mitizax (allergy immunotherapy tablet [dust mite]) Ryzodeg (insulin degludec/insulin aspart) Huntexil (pridopidine) ISIS-APOCIIIRx, ISIS-304801 RP-5063 TBA (auriclosene) TBA (betrixaban) TBA (dipraglurant) TBA (elagolix) TBA (ertugliflozin) TBA (lasmiditan) TBA (sotagliflozin) TBA (surotomycin) TBA (valbenazine) Zydena (udenafil) TBA (baclofen/ naltrexone/sorbitol) Ideglira (insulin degludec/liraglutide) BCT-197 BGS-649 LFF-571 LIK-066 QAW-039 TBA (amilomotide) TBA (mometasone/indacaterol) Addex Therapeutics AbbVie Merck, Pfizer CoLucid Lexicon Cubist Neurocrine Warner Chilcott 2016 (filing*) Oral Anemia associated with CKD 2018 (filing*) CM-AT Astellas, AstraZeneca Curemark Oral uncertain Misopress (misoprostol) Ferring Vaginal Autism Decrease birthing time to vaginal delivery for women who have an unfavorable cervix TBA (roxadustat) uncertain 12 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 Drug Name Afrezza (insulin human [rDNA origin] inhalation powder) Bunavail (buprenorphine/naltrexone) Epanova (eicosapentaenoic acid/docosahexaenoic acid) Ximino (minocycline ER) Zecuity (sumatriptan transdermal) TBA (insulin glargine) Lecette (desogestrel/ ethinyl estradiol) TBA (indomethacin submicron) Zalviso (sufentanil) Alisade (fluticasone furoate) Genvir (acyclovir) Contrave (naltrexone/ bupropion ER) TBA (budesonide) TBA (rizatriptan) Zerenex (ferric citrate coordination complex) Natpara (recombinant human parathyroid hormone) Rytary (carbidopa/ levodopa) TBA (liraglutide) Rasuvo (methotrexate) Rextoro (testosterone undecanoate) TBA (sumatriptan intranasal) CompleoTRT (testosterone intranasal) GeNOsyl MVG-2000 (nitric oxide delivery system) Humalog (insulin lispro) Levadex (dihydroergotamine) MoxDuo IR (morphine/oxycodone) Plumiaz (diazepam) TBA (amphetamine polistirex) TBA (granisetron SR) TBA (norethindrone transdermal delivery system) TBA (levetiracetam ER) Anoheal (diltiazem) Toujeo (insulin glargine) Manufacturer Route of Administration Indication(s) / Use Estimated FDA Filing / Approval / Market Date MannKind Inhalation Type 1 & type 2 diabetes approved† BioDelivery Oral Opioid dependence approved† Oral High triglycerides approved† Oral Moderate to severe acne approved† NuPathe Transdermal Migraine approved† Sanofi SubQ Type 1 & type 2 diabetes 3Q2014 Teva Oral Prevention of pregnancy JUL 2014 Iroko Oral Pain JUL 2014 AcelRx Sublingual Moderate-to-severe acute pain in hospital setting JUL 2014 Inhalation Asthma AUG 2014 Oral Herpes simplex virus infection AUG 2014 Oral Weight loss SEP 2014 Rectal Mild to moderate ulcerative colitis SEP 2014 Oral Acute migraine SEP 2014 Keryx, Panacor Oral Hyperphosphatemia in end-stage renal disease SEP 2014 NPS, Takeda SubQ Hypoparathyroidism OCT 2014 Impax Novo Nordisk Medac Clarus Therapeutics OptiNose, Avanir Oral SubQ SubQ Parkinson’s disease Weight management Rheumatoid arthritis, psoriasis OCT 2014 OCT 2014 NOV 2014 Oral Testosterone deficiency NOV 2014 Nasal Acute treatment of migraine NOV 2014 Trimel Nasal Male hypogonadism 2014 GeNO Inhalation Hypoxic respiratory failure in neonate 2014 Eli Lilly Map, Nektar, Allergan RxPharma, Actavis Acorda Therapeutics Neos Therapeutics AP Pharma SubQ Type 1 & Type 2 diabetes 2014 Inhalation Migraine 2014 Oral New oral formulation for moderate to severe acute pain 2014 Nasal Seizures 2014 Oral ADHD 2014 SubQ Chemotherapy-induced nausea & vomiting 2014 Actavis Topical Prevention of pregnancy 2014 Sun Ventrus, SLA Pharma Sanofi Oral Epilepsy 2014 Topical Pain associated with anal fissure 2Q2014 (filing*) SubQ Type 1 & type 2 diabetes 2Q2014 (filing*) Omthera, AstraZenca Ranbaxy GlaxoSmith Kline Flamel Technologies Orexigen, Takeda Salix RedHill BioPharma, IntelGenX 13 TBA (benzhydrocodone) KemPharm Oral Abuse-deterrent treatment of moderate to severe pain 3Q2014 (filing*) Androxal (enclomiphene citrate) Spiriva Respimat (tiotropium bromide) Repros Oral Secondary hypogonadism 4Q2014 (filing*) Boehringer Ingelheim Inhalation COPD 4Q2014 (filing*) Sustol (granisetron SR) Heron SubQ Chemotherapy-induced nausea & vomiting 4Q2014 (re-filing*) Novartis Inhalation Moderate to severe COPD 4Q2014 (filing*) Oral Abuse-deterrent treatment of chronic pain 4Q2014 (filing*) Oral Oral Abuse-deterrent treatment of chronic pain Abuse-deterrent treatment of chronic pain Oral Secondary amenorrhea 4Q2014 (filing*) 4Q2014 (filing*) 4Q2014 – 2015 (filing) Vectura, Novartis Inhalation Asthma, COPD 4Q2014 – 2016 (filing*) Biofrontera Topical Actinic keratosis 2014 (filing*) TBA (glycopyrronium bromide/indacaterol) TBA (hydrocodone bitartrate ER) TBA (morphine ER) TBA (oxycodone ER) TBA (progesterone) Seebri Breezhaler (glycopyrronium bromide long-acting) Ameluz (5-aminolevulinic acid nanocolloidal) Cephalon, Teva Egalet Collegium TherapeuticsM D Amiket (ketamine/amitriptyline) EpiCept Topical Asacard (acetylsalicylic acid) Flamel, NewHaven Oral Bromsite (bromfenac) InSite Vision Ophthalmic CCP-01 Tris, Vernalis Ventrus Biosciences, SLA Pharma Teva Oral Neuropathic pain associated with chemotherapy-induced peripheral neuropathy in patients previously treated with taxane-based chemotherapy Secondary prevention of cardiovascular disease Pain, swelling, & inflammation associated with ocular surgery Cough, cold Topical Pain associated with anal fissures 2014 (filing*) Inhalation 2014 (filing*) Salix SubQ Asthma Opioid-induced constipation in chronic pain AstraZeneca Inhalation Asthma, COPD 2014 (filing*) RedHill Insys Therapeuics Oral Hypertension, heart failure 2014 (filing*) Oral Chemotherapy-induced nausea & vomiting 2014 (filing*) Dolizem (diltiazem) Proair Spiromax (albuterol) Relistor (methylnaltrexone bromide) Symbicort (budesonide/formoterol) TBA (carvedilol CR) TBA (dronabinol) Binge eating disorder 2014 (filing*) Piethora Lightlake Therapeutics TBA (ondansetron) RedHill Oral TBA (tadalafil) IntelGenX GlaxoSmithKline, theravance TBA (cough/ cold therapy ER) Visonac (methyl aminoevulinate) TBA (esketamine) 2014 (filing*) Nasal TBA (lidocaine/prilocaine) Orfadin (nitisinone) 2014 (filing*) 2014 (filing*) Oral Vycavert (hydrocodone/ acetaminophen) Zubsolv (buprenorphine/ naloxone) Bema LA (buprenorphine buccal) Viviant (bazedoxifene) 2014 (filing*) Topical Vitra, Shield TBA (vilanterol) 2014 (filing*) Iron deficiency anemia associated with inflammatory bowel disease Premature ejaculation TBA (ferric trimaltol) TBA (naloxone) 2014 (filing*) 2014 (filing*) Oral Prevention of nausea & vomiting in cancer patients Erectile dysfunction 2014 (filing*) Inhalation COPD 2014 (filing*) Acura Oral Moderate to severe pain 2014 (filing*) Orexis Sublingual Opioid dependence 2014 (filing*) Oral Moderate to severe chronic pain Oral Postmenopausal osteoporosis 2014 – 2015 (filing*) 2014 (re-filing*) Oral Hereditary tyrosinemia type 1 2014 (re-filing*) Tris, Vernalis Oral Cough, cold Photocure Topical Acne Janssen Nasal Depression BioDelivery, Endo Pfizer Swedish Orphan Biovitrum 2014 (filing*) 2014 – 2015 (filing*) 2014 – 2015 (filing*) 2014 – 2017 (filing*) 14 SubQ Type 1 and type 2 diabetes 1Q2015 transdermal Hemostasis during surgery JAN 2015 Purdue Oral Abuse-deterrent treatment of chronic pain FEB 2015 Remoxy (oxycodone controlled-release) Pfizer, Pain Therapeutics Durect Oral Moderate to severe chronic pain 2015 Rayaldy, Replidea (calcifediol) Cytochroma Oral Secondary hyperpara-thyroidism associated with vitamin D insufficiency in patients with CKD 1Q2015 (filing*) Vagicap (estradiol) TherapeuticsM D Vaginal Postmenopausal vulvar & vaginal atrophy 3Q2015 (filing*) TBA (hydrocodone/ acetaminophen ER) Mallinckrodt Oral Abuse-deterrent treatment of chronic pain TBA (ramelteon) Takeda Sublingual Acute & maintenance therapy of bipolar I disorder TBA (amikacin) Bayer, Nektar Inhalation Gram negative bacterial respiratory tract infections 4Q2015 (filing*) TBA (estradiol/progesterone) TherapeuticsM D Oral Menopause symptoms 4Q2015 (filing*) Biodel SubQ AstraZeneca Actavis Watson, Gedeon Richter SLA Pharma, Ventrus Tarsa Therapeutics, Unigene NeurogesX Highland Therapeutics Egalet Cosmo TBA (insulin peglispro) FibroCaps (fibrinogen/thrombin) TBA (hydrocodone bitartrate ER) BIOD-Stable Glucagon (premixed stable glucagon) Bydureon (exenatide CR) Delzicol (mesalamine DR) Esmya (ulipristal acetate) Incostop (phenylephrine) Ostora (calcitonin/ recombinant salmon) TBA (capsaicin) TBA (methylphenidate ER) Eli Lilly The Medicines Company MAR – APR 2015 (filing*) APR 2015 – MAR 2016 (filing*) SubQ Oral Hypoglycemia caused by insulin overdose or congenital hyperinsulinism Type 2 diabetes Ulcerative colitis 2015 (filing*) 2015 (filing*) Oral Anemia associated with uterine leiomyomas 2015 (filing*) Rectal Fecal incontinence 2015 (filing*) Oral Postmenopausal osteoporosis 2015 (filing*) Topical Neuropathic pain 2015 (filing*) Oral ADHD 2015 (filing*) Oral Oral Pain Gastroenteritis 2015 (filing*) 2015 (filing*) 2015 (filing*) TBA (oxycodone) TBA (rifamycin SV MMX) TBA (testosterone undecanoate) Tefina (testosterone) Vibex QS T (testosterone) Lipocine Oral Male hypogonadism 2015 (filing*) M et P Pharma Antares Nasal SubQ Female sexual arousal disorder Hypogonadism Tresiba (insulin degludec) Novo Nordisk SubQ Type 1 & type 2 diabetes 2015 (filing*) 2015 (filing*) 2015 – 2016 (re-filing*) Twirla (ethinyl estradiol/levonorgestrel) Agile Therapeutics Sucampo, Takeda Cynapsus BioDelivery Intarcia Therapeutics Transdermal Prevention of pregnancy 2016 Oral Chronic idiopathic constipation 2016 (filing*) Sublingual Topical Parkinson’s disease Painful diabetic neuropathy 2016 (filing*) 2016 (filing*) SubQ Type 2 diabetes 2016 (filing*) KemPharma Oral Chronic pain 2016 (filing*) Makindus Ophthalmic Stargardt’s disease 2017 (filing*) KemPharma, Monosol Rx Oral ADHD 2017 (filing*) Winston Topical Osteoarthritis uncertain Amitiza (lubiprostone) TBA (apomorphine) TBA (clonidine) TBA (exenatide SR) TBA (hydromorphone prodrug) TBA (echothiophate iodide) TBA (methylphenidate prodrug/ligand) TBA (zucapsaicin/ ciscapsaicin) 15 SPECIALTY Specialty Generic Drugs Pipeline † indicates the medication has been approved but may or may not be available * indicates the medication is anticipated to be filed with the FDA at the listed date Generic Name Brand Name Brand Manufacturer Route of Administration Indication(s) / Use Estimated Approval / Market Date glatiramer acetate Copaxone Injection MS 1Q2015 entecavir Baraclude Oral Hepatitis B FEB 2015 efavirenz Sustiva Oral Antiviral MAR 2015 epinephrine bexarotene bosentan imatinib abacavir/ lamivudine lamivudine/ abacavir/ zidovudine lopinavir/ ritonavir ritonavir abiraterone acetate Epipen Targretin Tracleer Gleevec Teva Bristol Myers Squibb Bristol-Myers Squibb Mylan Eisai Actelion Novartis Injection Oral, Topical Oral Oral JUN 2015 JUL 2015 NOV 2015 FEB 2016 Epzicom GlaxoSmithKline Oral Anaphylactic reactions Cutaneous T-cell lymphoma Pulmonary arterial hypertension Cancers (CML, ALL, etc.) Human immunodeficiency virus (HIV) infection Trizivir ViiV Healthcare Oral HIV MAR 2016 Kaletra Abbott Oral Antiviral DEC 2016 Norvir Zytiga Oral Oral HIV infection Prostate cancer DEC 2016 DEC 2016 atazanavir Reyataz Oral Antiretroviral JUL 2017 tadalafil tenofovir efavirenz/emtricitabine/ tenofovir fentanyl Adcirca Viread AbbVie Janssen Bristol-Myers Squibb Synthon Gilead Oral Oral Pulmonary arterial hypertension Antiviral NOV 2017 JAN 2018 Atripla Gilead Oral Antiviral AUG 2018 Fentora Cephalon Buccal Breakthrough cancer pain OCT 2018 Specialty Brand Drugs Pipeline MAR 2016 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 Drug Name Manufacturer Route of Administration Cerdelga (eliglustat tartrate) Genzyme Oral Gaucher disease type 1 Elonva (corifollitropin alfa) Merck SubQ Infertility TBA (ceritinib) Novartis Oral TBA (idelalisib) Gilead Sciences Oral TBA (dolutegravir/ lamivudine/abacavir) Tybost (cobicistat) Vitekta (elvitegravir) Esbriet (pirfenidone) Faridak (panobinostat) Solorel (macimorelin acetate) TBA (asunaprevir) TBA (daclatasvir) TBA (faldaprevir) TBA (veruprevir/ritonavir/ ombitsavir/desabuvir) GlaxoSmithKline, Viiv, Shionogi Gilead Gilead Sciences InterMune Novartis Aeterna Zentaris Bristol Myers Squibb Bristol Myers Squibb Boehringer Ingelheim Enanta, AbbVie Indication(s) / Use Anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer Cancers (Chronic lympocytic leukemia (CML), indolent Non-Hodgkin’s Lymphoma Estimated FDA Filing / Approval / Market Date JUN 2014 JUN – JULY 2014 3Q – 4Q 2014 AUG – SEP 2014 Oral HIV OCT 2014 Oral Oral Oral Oral HIV HIV Idiopathic pulmonary fibrosis Multiple myeloma Growth hormone deficiency, treatment of cachexia OCT 2014 OCT 2014 NOV 2014 NOV 2014 Oral Hepatitis C virus infection DEC 2014 Oral Hepatitis C virus infection DEC 2014 Oral Hepatitis C virus infection DEC 2014 Oral Hepatitis C virus infection DEC 2014 Oral NOV 2014 16 TBA (apremilast) TBA (dasabuvir) TBA (ombitasvir) TBA (veruprevir) TBA (veruprevir/ritonavir/ ombitasvir) Celgene AbbVie AbbVie AbbVie Oral Oral Oral Oral Psoriatic arthritis Hepatitis C Hepatitis C virus infection Hepatitis C virus infection 2Q2014 (filing*) 2Q2014 (filing*) 2Q2014 (filing*) 2Q2014 (filing*) AbbVie Oral Hepatitis C virus infection 2Q2014 (filing*) TBA (alisertib) Takeda Oral Peripheral T-cell lymphoma TBA (palbociclib) Pfizer, Onyx Oral Metastatic breast cancer Iressa (gefitinib) AstraZeneca Oral Non-small cell lung cancer TBA (apricitabine) Avexa Oral Multidrug resistant HIV infection SubQ Severe uncontrolled refractory asthma 4Q2014 (filing*) SubQ Cholesterol 4Q2014 (filing*) Bosatria (mepolizumab) TBA (alirocumab) GlaxoSmithKline Regeneron, Sanofi Aventis TBA (lomibuvir) Vertex Oral Hepatitis C virus infection Cinquil (reslizumab) TBA (acolbifene) TBA (avatrombopag) UCB Endoceutics Eisai SubQ Oral Oral TBA (cobimetinib) Genentech Oral TBA (danoprevir) TBA (drisapersen) TBA (eteplirsen) TBA (lenvatinib mesylate) Roche Prosensa AVI BioPharma Eisai Oral SubQ -Oral TBA (lumacaftor) Vertex Oral TBA (lumacaftor/ivacaftor) Vertex Oral Eosinophilic asthma Breast Cancer Immune thrombocytopenic purpura In combination with Zelboraf for metastatic melanoma Hepatitis C virus infection Duchenne muscular dystrophy (DMD) Duschenne muscular dystrophy Endometrial cancer, thyroid cancer Cystic fibrosis homozygous for F508del CFTR mutation Cystic fibrosis homozygous for F508del CFTR mutation TBA (mericitabine) TBA (migalastat) TBA (sonidegib/erismodegib) TBA (telatinib) TBA (tildrakizumab) TBA (deleobuvir) Pharmasset, Roche Amicus Therapeutics, GlaxoSmithKline Novartis ACT Biotech, Bayer Merck Boehringer Ingelheim 2014 (filing*) Oral Advanced basal cell carcinoma 2014 (filing*) Oral Gastric cancer 2014 (filing*) SubQ Psoriasis Oral Hepatitis C virus infection >2014 (filing*) 2014 – 2015 (filing*) 2014 – 2015 (filing*) Eleison,Threshold Pharmaceuticals IV Pancreatic cancer TBA (momelotinib) Gilead Sciences Oral Myelofibrosis TBA (gevokizumab) Xoma SubQ Pyoderma gangrenosum, non-infectious uveitis, Behcet’s disease JNJ-56914845 (GSK2336805, GSK-805) Janssen Oral Chronic hepatitis C TBA (guselkumab) Janssen SubQ Psoriasis, rheumatoid arthritis SubQ Rheumatoid arthritis, lupus nephritis TBA (darunavir/cobicistat) 2014 (filing*) Fabry disease TBA (glufosfamide) TBA (atazanavir/cobicistat) 2014 (filing*) Oral Anemia associated with CKD & cancer TBA (secukinumab) 2014 (filing*) 2014 (filing*) 2014 (filing*) 2014 (filing*) 2014 (filing*) SubQ Vargatef (nintedanib) 2014 (filing*) Hepatitis C virus infection Hospira Janssen, GlaxoSmith Klein Boehringer Ingelheim Novartis Bristol Myers Squibb, Gilead Sciences Janssen, Gilead 4Q2014 – 1Q2015 (filing*) 2014 (filing*) 2014 (filing*) 2014 (filing*) Oral TBA (erythropoietin biosimilar) TBA (sirukumab) APR 2014 – MAR 2015 (filing*) 3Q2014 (filing*) 3Q2014 (re-filing*) 3Q-4Q 2014 (filing*) 2014 – 2015 (filing*) 2014 – 2015 (filing*) 2014 – 2016 (filing*) 2014 – 2017 (filing*) 2014 – 2017 (filing*) 2014 – 2017+ (filing*) SubQ; IV Idiopathic pulmonary fibrosis; non-small cell lung cancer; ovary tumor Moderate to severe plaque psoriasis Oral HIV FEB 2015 Oral HIV FEB 2015 Oral 1Q2015 – 2016+ JAN 2015 17 Firdapse (amifampridine phosphate) TBA (daclatasvir/asunaprevi/ beclabuvir) AZD-9291 CO-1686 Recentin (cediranib) Bristol Myers Squibb AstraZeneca Clovis, Celgene AstraZeneca Rydapt (midostaurin) Novartis TBA (beclabuvir) TBA (brodalumab) TBA (elbasvir) TBA (grazoprevir) TBA (ledipasvir) TBA (sarilumab) TBA (tasquinimod) TBA (trifluridine/tipiracil) Catalyst Bristol Myers Squibb Amgen, AstraZeneca Merck Merck Gilead Sciences Sanofi Aventis, Regeneron Active Biotech, Ipsen Taiho Pharmaceutical Oral Lambert-Eaton myasthenic syndrome 1Q2015 (filing*) Oral Hepatitis C virus infection 1Q2015 (filing*) Oral Oral Oral Non-small cell lung cancer Non-small cell lung cancer Ovarian cancer Acute myeloid leukemia, aggressive systemic mastocytosis 2015 (filing*) 2015 (filing*) 2015 (filing*) Oral Hepatitis C virus infection 2015 (filing*) SubQ Moderate to severe plaque psoriasis 2015 (filing*) Oral Oral Oral Chronic hepatitis C Chronic hepatitis C Hepatitis C virus infection Rheumatoid arthritis, ankylosing spondylitis 2015 (filing*) 2015 (filing*) 2015 (filing*) Oral Metastatic castrate-resistant prostate cancer 2015 (filing*) Oral Metastatic colorectal cancer 2015 (filing*) 2015-2016 (filing*) 2015 – >2017 (filing*) 2Q2016 (filing*) 2Q2016 (filing*) 2Q2016 (filing*) 2016 (filing*) 2016 (filing*) Oral SubQ TBA (romosozumab) UCB, Amgen SubQ Bone loss disorders, including postmenopausal osteoporosis and bone fractures TBA (buparlisib) Novartis Oral Breast cancer & solid tumors ACH-3102 TBA (sovaprevir) TG-4010 LCI-699 LEE-011 Proellex-V (telapristone acetate) TBA (benralizumab) TBA (binimetinib) TBA (binimetinib/encorafenib) Achillion Achillion Transgene Novartis Novartis Oral Oral SubQ Oral Oral Repros Oral AstraZeneca Novartis SubQ Oral Chronic hepatitis C Chronic hepatitis C Non-small cell lung cancer Cushing’s disease Metastatic breast cancer Severe menstrual bleeding associated with uterine fibroids Severe uncontrolled asthma NRAS melanoma Novartis Oral BRAF mutant melanoma TBA (bococizumab) Pfizer SubQ TBA (defactinib) TBA (dovitinib) TBA (encorafenib) TBA (lebrikizumab) Verastern Novartis Novartis Genentech Oral Oral Oral SubQ TBA (masitinib) AB Science Oral TBA (mericitabine) TBA (olaparib) TBA (pacritinib) TBA (setrobuvir) TBA (venetoclax) Translarna (ataluren) Pharmasset, Roche AstraZeneca Cell Therapeutics Roche AbbVie, Genentech, Roche PTC Therapeutics Hyperlipidemia, dyslipidemia, & heterozygous familial hypercholesterolemia Mesothelioma Renal cell cancer BRAF mutant melanoma Asthma Rheumatoid arthritis, asthma, amyotrophic lateral sclerosis, gastrointestinal stromal tumor 2015 (filing*) 2015 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) 2016 (filing*) Oral Chronic hepatitis C 2016 (filing*) Oral BRCA-mutated ovarian cancer 2016 (filing*) Oral Myelofibrosis 2016 (filing*) Oral Hepatitis C virus infection 2016 (filing*) Oral Chronic lymphocytic leukemia 2016 (filing*) Oral Nonsense mutation duchenne muscular dystrophy Metastatic gastric or gastroesophageal junction cancer TBA (ipatasertib dihydrochloride) Genentech Oral FSH-GEX, GT-GP 2.4 GEX Glycotype SubQ Infertility TBA (selumetinib) BGJ-398 BYL-719 TBA (alisporivir) TBA (dactolisib) TBA (quilizumab) TBA (siponimod) AstraZeneca Novartis Novartis Novartis Novartis Novartis Novartis Oral Oral Oral Oral Oral SubQ Oral KRAS+ non-small cell lung cancer Solid tumors Solid tumors Hepatitis C virus infection Solid tumors Allergic diseases Secondary progressive MS 2016 (filing*) >2016 (filing*) 2016 – 2017 (filing*) 2017 (filing*) >2017 (filing*) >2017 (filing*) >2017 (filing*) >2017 (filing*) >2017 (filing*) >2017 (filing*) 18 Specialty Brand Drugs Pipeline — New Formulations TBA = to be announced † indicates the medication has been approved but may or may not be available * indicates the medication is anticipated to be filed with the FDA at the listed date Manufacturer Route of Administration Indication(s) / Use Estimated FDA Filing / Approval / Market Date Biogen Idec SubQ Relapsing forms of MS AUG 2014 Baxter, Halozyme SubQ Primary immunodeficiency in adults SEP 2014 Xaluprine (mercaptopurine) Nova, Rare Disease Therapeutics Oral Acute lymphoblastic leukemia 4Q2014 Envarsus (tacrolimus) Veloxis Oral Drug Name Plegridy (peginterferon beta-1a) Hyqvia (immunoglobulin [human]/hyaluronidase [human, recombinant]) TBA (sofosbuvir/ledipasvir) Pharmacyclics, Janssen Gilead Kalbitor (ecallantide) Dyax Imbruvica (ibrutinib) TBA (filgrastim biosimilar) Lonquex (lipegfilgrastim) TBA (treprostinil diethanolamine) TBA (daclizumab) Pan Pharmaceuticals Harvest Moon Pharmaceuticals Teva United Therapeutics Biogen Idec, AbbVie Arikace (amikacin liposomal) Insmed, Transave Kalydeco (ivacaftor) Vertex Chiasma, Roche Ablynx Gilead Sciences Octreolin (ocreotide acetate) TBA (caplacizumab) TBA (tenofovir alafenamide) Oral Oral SubQ Improved tablet formulation for kidney transplant rejection prevention Chronic lymphocytic leukemia, small lymphocytic leukemia Hepatitis C virus infection Concentrated formulation for hereditary angioedema OCT 2014 OCT 2014 OCT 2014 2014 SubQ Neutropenia 2014 SubQ Chemotherapy-induced neutropenia 2014 Oral Pulmonary arterial hypertension 2014 SubQ Relapsing remitting MS 4Q2014 (filing*) Oral Gram-negative lung infections caused by pseudomonas aeruginosa in patients with cystic fibrosis & bronchiectasis, nontuberculous mycobacteria lung infections Cystic fibrosis 2014 (filing*) Oral Acromegaly 2014 (filing*) SubQ Thrombotic thrombocytopenic purpura 2014 (filing*) Oral HIV in treatment-naïve adults 1Q2015 (filing*) Inhalation Chronic pseudomonas aeruginosa lung infections in bronchiectasis 4Q2015 (filing*) Inhalation 2014 (filing*) TBA (ciprofloxacin dry powder inhalation) BA-058, BIM-44058, ITM-058 for LAR (pasireotide) TBA (growth hormone) TBA (peginterferon lambda-1a) Phenylase (phenylalanine hydroxylase) Redium Health, Teijin Novartis Prolor Biotech Bristol Myers Squibb SubQ Postmenopausal osteoporosis 2015 (filing*) SubQ SubQ Cushing’s syndrome Growth hormone deficiency Hepatitis B virus infection, hepatitis C virus infection 2015 (filing*) 2015 (filing*) BioMarin SubQ Phenylketonuria 1Q2016 (filing*) TBA (etanercept biosimilar) Baxter, Daiichi Sankyo, Coherus SubQ Rheumatoid arthritis 2016 (filing*) Bayer, Nektar SubQ >2015 (filing*) References: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Pharmacist’s Letter, Anticipated Availability of First-Time Generics, Therapeutic Research Center, 3120 W. March Lane, PO Box 8190, Stockton, 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 Rx Outlook: Generic Pipeline December 2013-December 2016, SXC Drug Information Services, 2013 SXC Health Solutions, Inc. Volume 7, Issue 12, 4th Quarter 2013 Rx Outlook: Generic Pipeline June 2014 to June 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 4, 2nd Quarter 2014 Rx Outlook: Generic Pipeline March 2014 to March 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 1, 1st Quarter 2014 Rx Outlook: Non-specialty pipeline – Q1 2014 to 2018, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 2, 1st Quarter 2014 Rx Outlook: Non-specialty pipeline – Q4 2013 to 2017, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 13, 4th Quarter 2013 Rx Outlook: Non-specialty pipeline – 2014 to 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 5, 2nd Quarter 2014 Rx Outlook: Specialty pipeline – Q1 2014 to 2018, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 3, 1st Quarter 2014 Rx Outlook: Specialty pipeline – Q4 2013-2017, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 13, 4th Quarter 2013 Rx Outlook: Specialty pipeline – 2014 to 2017, Catamaran Inc. Drug Intelligence Services, 2014 Catamaran Inc. Volume 8, Issue 6, 2nd Quarter 2014 19