FDA Approved New Drugs 2017

First-Time Generic Drug Approvals 2017
  • Estrace (Estradiol) - Mylan Pharmaceuticals Inc.
  • Advil Cold and Sinus (Ibuprofen and Pseudoephedrine Hydrochloride) - Aurobindo Pharma Limited
  • Lioresal (Baclofen) - Rubicon Research Private Limited
  • Biltricide (Praziquantel) - Par Pharmaceutical, Inc.
  • Capastat Sulfate (Capreomycin) - Mylan Laboratories Limited
  • Trokendi (Topiramate) - Zydus Pharmaceuticals (USA), Inc
  • Locoid (Hydrocortisone Butyrate) - Teligent Pharma, Inc.
  • Prezista (Darunavir) - Teva Pharmaceuticals USA, Inc.
  • Abstral (Fentanyl) - Actavis Laboratories FL, Inc.
  • Fluoxetine Tablets, 60 mg - Par Pharmaceuticals, Inc.
  • Lotrimin (Butenafine Hydrochloride) - Taro Pharmaceuticals USA Inc.
  • Sodium Acetate Injection USP, 400 mEq/100 mL - Fresenius Kabi USA, LLC
  • Methadone Hydrochloride Injection USP, 200 mg/20 mL - Akorn, Inc.
  • Coreg CR (Carvedilol Phosphate) - Sun Pharmaceutical Industries Inc.
  • Klor-Con® Powder (Potassium Chloride for Oral Solution USP) - Upsher-Smith Laboratories, Inc.
  • Aczone (Dapsone) - Taro Pharmaceuticals USA Inc.
  • Nuedexta (Dextromethorphan Hydrobromide and Quinidine Sulfate) - Actavis Elizabeth LLC
  • Copaxone (Glatiramer Acetate) - Mylan Pharmaceuticals Inc.
  • Cancidas (Caspofungin Acetate) - Gland Pharma Limited
  • Isopto Carpine (Pilocarpine Hydrochloride) - Akorn Inc.
  • Testim (Testosterone) - Actavis Laboratories UT, Inc.
  • Tamiflu (Oseltamivir Phosphate) - Nesher Pharmaceuticals (USA) LLC
  • Docetaxel Injection - Ingenus Pharmaceuticals, LLC
  • Prograf (Tacrolimus) - Hospira, Inc.
  • Akovaz (Ephedrine Sulfate) - Sandoz Inc.
  • Nexium 24HR (Esomeprazole Magnesium) - Perrigo R&D Company
  • Fosrenol (Lanthanum Carbonate) - Natco Pharma Limited
  • Taxotere (Docetaxel) - Jiangsu Hengrui Medicine Co., Ltd.
  • Effient (Prasugrel) - Mylan Pharmaceuticals
  • Brisdelle (Paroxetine) - Actavis Laboratories FL, Inc.
  • Lialda (Mesalamine) - Zydus Pharmaceuticals (USA) Inc.
  • Strattera (Atomoxetine) - Glenmark Pharmaceuticals Limited
  • Clolar (Clofarabine) - Abon Pharmaceuticals, LLC
  • Seroquel XR (Quetiapine Fumarate) - Accord Healthcare Inc.
  • Seroquel XR (Quetiapine Fumarate) - Pharmadax Inc.
  • Seroquel XR (Quetiapine Fumarate) - Par Pharmaceutical Inc.
  • Seroquel XR (Quetiapine Fumarate) - IntelliPharmaCeutics Corp.
  • Dymista (Azelastine Hydrochloride and Fluticasone Propionate) - Apotex Inc.
  • Sabril (Vigabatrin) - Par Pharmaceutical, Inc.
  • Vytorin (Ezetimibe and Simvastatin) - Impax Laboratories Inc.
  • Vytorin (Ezetimibe and Simvastatin) - Watson Laboratories, Inc.
  • Vytorin (Ezetimibe and Simvastatin) - Dr. Reddys Laboratories International SA
  • Liptruzet (Ezetimibe and Atorvastatin) - Watson Laboratories, Inc.
  • Rayos (Prednisone) - Actavis Laboratories FL Inc
  • Dexilant (Dexlansoprazole Delayed-Release) - Par Pharmaceutical Inc.
  • Tazorac and Avage (Tazarotene) - Taro Pharmaceuticals USA, Inc.
  • Rapaflo (Silodosin) - Sandoz Inc.
  • Venlafaxine Hydrochloride ER (Venlafaxine Hydrochloride) - Nostrum Laboratories, Inc.
  • Alkeran (Melphalan) - Alvogen Malta Operations Ltd.
  • Zyflo CR (Zileuton) - Pack Pharmaceuticals, LLC
  • Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate) - Lupin Inc.
  • Ella (Ulipristal Acetate) - Teva Pharmaceuticals USA, Inc.
  • Suprax (Cefixime) - Belcher Pharmaceuticals, LLC
  • Namzaric (Memantine and Donepezil Hydrochlorides) - Amneal Pharmaceuticals LLC
  • Ampyra (Dalfampridine) - Actavis Laboratories FL, Inc.
  • Ampyra (Dalfampridine) - (Aurobindo Pharma Limited)
  • Xyrem (Sodium Oxybate) - Roxane Laboratories, Inc.
  • Levetiracetam in Sodium Chloride - Aurobindo Pharma Limited

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