Generic Launches

Fall 2016

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Fenoglide	Santarus	Fenofibrate Tablets	Mylan	indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, Triglycerides, and apolipoprotein B to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia	7/6/2016
Paxil CR	Apotex	Paroxetine Extended-Release Tablets	Lannett	used to treat depression	7/11/2016
Temodar	Merck	Temozolomide Capsules	Mylan	indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment	7/11/2016
Zegerid	Santarus	Omeprazole / Sodium Bicarbonate Capsules	Ajanta	short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE	7/18/2016
Nilandron	Covis Pharmaceuticals	Nilutamide Tablets	ANI Pharmaceuticals	indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2)	7/18/2016
Zegerid	Santarus	Omeprazole / Sodium Bicarbonate Capsules	Dr. Reddy's Laboratories	short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE	7/18/2016
Zegerid OTC	Merck	Omeprazole / Sodium Bicarbonate OTC Capsules	Perrigo	short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE	7/18/2016
Axert	Janssen	Almotriptan Malate Tablets	Ajanta	indicated for acute migraine pain treatment for adults and teens	7/19/2016
Crestor	AstraZeneca	Rosuvastatin Calcium Tablets	Citron Pharma	is an antihyperlipidemic to prevent cardiovascular disease	7/19/2016
Crestor	IPR Pharmaceuticals	Rosuvastatin Calcium Tablets	Aurobindo Pharma	is an antihyperlipidemic to prevent cardiovascular disease	7/20/2016
Xeloda	Hoffmann-La Roche	Capecitabine Tablets	Hikma Pharmaceuticals / West-Ward Pharmaceuticals	indicated for adjuvant treatment in patients with Dukes' C colon cancer, as monotherapy in metastatic colorectal cancer, and in combination with docetaxel or as montherapy in patients with metastatic breast cancer	7/20/2016
Ortho Tri-Cyclen	Johnson & Johnson	Norgestimate / Ethinyl Estradiol Tablets	Lupin	indicated for use by females of reproductive potential to prevent pregnancy	7/20/2016
Crestor	AstraZeneca	Rosuvastatin Calcium Tablets	Mylan	is an antihyperlipidemic to prevent cardiovascular disease	7/20/2016
Crestor	IPR Pharmaceuticals	Rosuvastatin Calcium Tablets	Apotex	is an antihyperlipidemic to prevent cardiovascular disease	7/22/2016
Propecia	Merck	Finasteride Tablets	Mylan	treatment of male pattern hair loss (androgenetic alopecia) for men only	8/1/2016
Dexedrine	Amedra Pharmaceuticals	Dextroamphetamine Sulfate Extended-Release Capsules	Mylan	indicated in narcolepsy and attention deficit disorder with hyperactivity as an integral part of a total treatment program with typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome	8/1/2016
Gleevec	Novartis Oncology	Imatinib Mesylate Tablets	Teva	indicated for newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)	8/5/2016
Fusilev	Spectrum Pharmaceuticals	Levoleucovorin for Injection	Hikma Pharmaceuticals / West-Ward Pharmaceuticals	indicated for rescue after high dose methotrexate therapy in osteosarcoma and for diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists	8/16/2016
Nitrostat	Pfizer	Nitroglycerin Sublingual Tablets	Dr. Reddy's Laboratories	used to stop or prevent angina (chest pain).	8/29/2016
Wellbutrin XL	Valeant	Bupropion Hydrochloride Extended-Release Tablets (XL)	Cipla	an antidepressant used to treat Major Depressive Disorder (MDD) and Seasonal Affective Disorder (SAD)	8/30/2016
Enablex	Allergan	Darifenacin Extended-Release Tablets	Cipla	indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency	9/2/2016
Wellbutrin SR	GlaxoSmithKline	Bupropion HCI Extended-Release Tablets	Dr. Reddy's Laboratories	an antidepressant used to treat Major Depressive Disorder (MDD) and Seasonal Affective Disorder (SAD)	9/2/2016
Razadyne	Johnson & Johnson	Galantamine Tablets	Hikma Pharmaceuticals / West-Ward Pharmaceuticals	indicated for the treatment of mild to moderate dementia in patients with Alzheimer's disease	9/2/2016
Ortho-Cyclen 28	Ortho-McNeil	Femynor	Amneal	indicated for use by females of reproductive potential to prevent pregnancy	9/8/2016
Cubicin	Merck Sharp & Dohme	Daptomycin for Injection	Teva	indicated for treatment of complicated skin and skin structure infections and staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates	9/15/2016
Zemplar	Abbvie	Paricalcitol Injection	Dr. Reddy's Laboratories	used for the prevention and treatment of high levels of parathyroid hormone in certain patients with chronic kidney disease	9/19/2016
Cubicin	Merck	Daptomycin for Injection	Fresenius Kabi USA	indicated for treatment of complicated skin and skin structure infections and staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates	9/20/2016
Metadate CD	UCB	Methylphenidate Hydrochloride Extended-Release Capsules	Impax Laboratories	indicated for treatment of Attention Deficit Hyperactivity Disorder (ADHD)	9/22/2016
Zegerid	Santarus	Omeprazole / Sodium Bicarbonate Powder for Oral Suspension	Ajanta	short-term treatment of active benign gastric ulcer; active duodenal ulcer; erosive esophagitis (EE); symptomatic GERD; and the maintenance of healing of EE	9/26/2016
Cymbalta	Eli Lilly	Duloxetine Capsules	Camber Pharmaceuticals	used to treat depression and anxiety	9/27/2016
Epzicom	GlaxoSmithKline	Abacavir / Lamivudine Tablets	Teva	indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, abacavir and lamivudine tablets may help to: Reduce the amount of HIV-1 in affected patients' blood (viral load), and increase the number of CD4+ (T) cells in affected patients' blood to help fight off other infections	9/29/2016
Fortamet	Watson	Metformin Hydrochloride Extended-Release Tablets	Mylan	indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus	9/30/2016