Drug Approvals

Source: U.S. Food and Drug Administration

Updated: May 28, 2019

To view all recent drug appovals, click here.

May 28, 2019 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Revlimid NDA #021880 Lenalidomide Capsule; Oral SUPPL-57 Celgene Efficacy Approved May 24, 2019 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Dapagliflozin ANDA #211156 Dapagliflozin Unknown ORIG-1 Inventia Hlthcare Tentative Approval Jakafi NDA #202192 Ruxolitinib Phosphate Tablet; Oral SUPPL-17 Incyte Corp Efficacy Approved Pemetrexed Sodium ANDA #208262 Pemetrexed Sodium Unknown ORIG-1 Wockhardt Bio Ag Tentative Approval Piqray NDA #212526 Alpelisib Tablet; Oral ORIG-1 Novartis Pharms Corp Type 1 - New Molecular Entity Approved May 23, 2019 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Lyrica NDA #021446 Pregabalin Capsule; Oral SUPPL-36 Pf Prism Cv Efficacy Approved Lyrica NDA #022488 Pregabalin Solution; Oral SUPPL-14 Pf Prism Cv Efficacy Approved Pemetrexed Disodium NDA #211090 Pemetrexed Disodium Unknown ORIG-1 Biocon Pharma Ltd Tentative Approval Slynd NDA #211367 Drospirenone Tablet; Oral ORIG-1 Exeltis Usa Inc Type 2 - New Active Ingredient and Type 3 - New Dosage Form Approved Truxima BLA #761088 Rituximab-Abbs Injectable; Injection SUPPL-1 Celltrion Inc Efficacy Approved Truxima BLA #761088 Rituximab-Abbs Injectable; Injection SUPPL-2 Celltrion Inc Efficacy Approved May 22, 2019 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cyproheptadine Hydrochloride ANDA #212423 Cyproheptadine Hydrochloride Syrup; Oral ORIG-1 Quagen Approved Decitabine NDA #205582 Decitabine Powder; Intravenous SUPPL-9 Sun Pharma Global Labeling Approved Epidiolex NDA #210365 Cannabidiol Solution; Oral SUPPL-4 Gw Res Ltd Manufacturing (CMC) Approved Erlotinib ANDA #211083 Erlotinib Unknown ORIG-1 Accord Hlthcare Inc Tentative Approval Esomeprazole Magnesium ANDA #206296 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral ORIG-1 Zydus Pharms Approved Levofloxacin ANDA #091678 Levofloxacin Solution; Oral SUPPL-4 Hi Tech Pharma Labeling Approved Levofloxacin ANDA #091678 Levofloxacin Solution; Oral SUPPL-4 Hi Tech Pharma Labeling Approved Ofloxacin ANDA #076093 Ofloxacin Tablet; Oral SUPPL-11 Larken Labs Labeling Approved Ofloxacin ANDA #076093 Ofloxacin Tablet; Oral SUPPL-11 Larken Labs Labeling Approved Phytonadione ANDA #207719 Phytonadione Injectable; Injection ORIG-1 Dr Reddys Labs Ltd Approved Siklos NDA #208843 Hydroxyurea Tablet; Oral SUPPL-2 Addmedica Sas Labeling Approved Sotradecol ANDA #040541 Sodium Tetradecyl Sulfate Injectable; Injection SUPPL-15 Mylan Institutional Labeling Approved Sotradecol ANDA #040541 Sodium Tetradecyl Sulfate Injectable; Injection SUPPL-15 Mylan Institutional Labeling Approved Trientine Hydrochloride ANDA #211134 Trientine Hydrochloride Capsule; Oral ORIG-1 Msn Labs Pvt Ltd Approved May 21, 2019 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cleocin NDA #050680 Clindamycin Phosphate Cream; Vaginal SUPPL-17 Pharmacia and Upjohn Labeling Approved Dalfampridine ANDA #208292 Dalfampridine Tablet, Extended Release; Oral ORIG-1 Sun Pharm Approved Donepezil Hydrochloride ANDA #077518 Donepezil Hydrochloride Tablet; Oral SUPPL-2 Cipla Ltd Labeling Approved Donepezil Hydrochloride ANDA #090056 Donepezil Hydrochloride Tablet; Oral SUPPL-10 Aurobindo Labeling Approved Donepezil Hydrochloride ANDA #090290 Donepezil Hydrochloride Tablet; Oral SUPPL-9 Sandoz Labeling Approved Donepezil Hydrochloride ANDA #201724 Donepezil Hydrochloride Tablet; Oral SUPPL-5 Alembic Pharms Ltd Labeling Approved Donepezil Hydrochloride ANDA #202723 Donepezil Hydrochloride Tablet; Oral SUPPL-4 Dr Reddys Labs Ltd Labeling Approved Donepezil Hydrochloride ANDA #202723 Donepezil Hydrochloride Tablet; Oral SUPPL-5 Dr Reddys Labs Ltd Labeling Approved Donepezil Hydrochloride ANDA #202723 Donepezil Hydrochloride Tablet; Oral SUPPL-5 Dr Reddys Labs Ltd Labeling Approved Losartan Potassium ANDA #202230 Losartan Potassium Tablet; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved Losartan Potassium ANDA #202230 Losartan Potassium Tablet; Oral SUPPL-10 Macleods Pharms Ltd Labeling Approved Paricalcitol ANDA #206699 Paricalcitol Solution; Intravenous SUPPL-1 Amneal Pharms Co Labeling Approved Welchol NDA #021176 Colesevelam Hydrochloride Tablet; Oral SUPPL-45 Daiichi Sankyo Labeling Approved Welchol NDA #022362 Colesevelam Hydrochloride For Suspension; Oral SUPPL-25 Daiichi Sankyo Labeling Approved Yupelri NDA #210598 Revefenacin Solution; Inhalation SUPPL-1 Mylan Ireland Ltd Labeling Approved May 20, 2019 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Albendazole ANDA #208094 Albendazole Tablet; Oral ORIG-1 Actavis Elizabeth Approved Apokyn NDA #021264 Apomorphine Hydrochloride Injectable; Subcutaneous SUPPL-16 Us Worldmeds Labeling Approved Apokyn NDA #021264 Apomorphine Hydrochloride Injectable; Subcutaneous SUPPL-16 Us Worldmeds Labeling Approved Dactinomycin ANDA #203999 Dactinomycin Injectable; Injection ORIG-1 X-Gen Pharms Inc Approved Dimethyl Fumarate ANDA #210492 Dimethyl Fumarate Unknown ORIG-1 Sun Pharm Inds Ltd Tentative Approval Donepezil Hydrochloride ANDA #090686 Donepezil Hydrochloride Tablet; Oral SUPPL-12 Torrent Pharms Labeling Approved Donepezil Hydrochloride ANDA #203656 Donepezil Hydrochloride Tablet; Oral SUPPL-1 Unichem Labs Ltd Labeling Approved Donepezil Hydrochloride ANDA #203656 Donepezil Hydrochloride Tablet; Oral SUPPL-1 Unichem Labs Ltd Labeling Approved Donepezil Hydrochloride ANDA #203656 Donepezil Hydrochloride Tablet; Oral SUPPL-1 Unichem Labs Ltd Labeling Approved Donepezil Hydrochloride ANDA #204609 Donepezil Hydrochloride Tablet; Oral SUPPL-2 Cadila Pharms Ltd Labeling Approved Donepezil Hydrochloride ANDA #204609 Donepezil Hydrochloride Tablet; Oral SUPPL-2 Cadila Pharms Ltd Labeling Approved Faslodex NDA #021344 Fulvestrant Injectable; Intramuscular SUPPL-39 Astrazeneca Labeling Approved Faslodex NDA #021344 Fulvestrant Injectable; Intramuscular SUPPL-39 Astrazeneca Labeling Approved Fulvestrant NDA #210326 Fulvestrant Injectable; Injection ORIG-1 Fresenius Kabi Usa Type 5 - New Formulation or New Manufacturer Approved Methylprednisolone Acetate ANDA #210043 Methylprednisolone Acetate Injectable; Injection ORIG-1 Amneal Pharms Co Approved Solifenacin Succinate ANDA #202551 Solifenacin Succinate Tablet; Oral ORIG-1 Watson Labs Inc Approved Solifenacin Succinate ANDA #205483 Solifenacin Succinate Tablet; Oral ORIG-1 Ajanta Pharma Ltd Approved Solifenacin Succinate ANDA #205575 Solifenacin Succinate Tablet; Oral ORIG-1 Alembic Pharms Ltd Approved Solifenacin Succinate ANDA #209239 Solifenacin Succinate Tablet; Oral ORIG-1 Glenmark Pharms Inc Approved Solifenacin Succinate ANDA #209333 Solifenacin Succinate Tablet; Oral ORIG-1 Qilu Pharm Co Ltd Approved Solifenacin Succinate ANDA #209719 Solifenacin Succinate Tablet; Oral ORIG-1 Amneal Pharms Co Approved Solifenacin Succinate ANDA #209818 Solifenacin Succinate Tablet; Oral ORIG-1 Breckenridge Pharm Approved Solifenacin Succinate ANDA #209839 Solifenacin Succinate Tablet; Oral ORIG-1 Cipla Approved Solifenacin Succinate ANDA #210224 Solifenacin Succinate Tablet; Oral ORIG-1 Alkem Labs Ltd Approved Solifenacin Succinate ANDA #210281 Solifenacin Succinate Tablet; Oral ORIG-1 Jiangxi Boya Seehot Approved Solifenacin Succinate ANDA #210582 Solifenacin Succinate Tablet; Oral ORIG-1 Airis Pharma Pvt Ltd Approved Solifenacin Succinate ANDA #210688 Solifenacin Succinate Tablet; Oral ORIG-1 Msn Labs Pvt Ltd Approved Solifenacin Succinate ANDA #211657 Solifenacin Succinate Tablet; Oral ORIG-1 Sciegen Pharms Inc Approved May 19, 2019 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Benazepril Hydrochloride ANDA #076820 Benazepril Hydrochloride Tablet; Oral SUPPL-18 Amneal Pharms Labeling Approved Letrozole ANDA #090289 Letrozole Tablet; Oral SUPPL-4 Teva Pharms Labeling Approved Letrozole ANDA #090289 Letrozole Tablet; Oral SUPPL-5 Teva Pharms Labeling Approved Letrozole ANDA #091303 Letrozole Tablet; Oral SUPPL-2 Apotex Inc Labeling Approved Letrozole ANDA #091303 Letrozole Tablet; Oral SUPPL-3 Apotex Inc Labeling Approved Letrozole ANDA #091303 Letrozole Tablet; Oral SUPPL-2 Apotex Inc Labeling Approved Letrozole ANDA #091303 Letrozole Tablet; Oral SUPPL-3 Apotex Inc Labeling Approved Letrozole ANDA #202716 Letrozole Tablet; Oral SUPPL-3 Jiangsu Hengrui Med Labeling Approved Letrozole ANDA #202716 Letrozole Tablet; Oral SUPPL-2 Jiangsu Hengrui Med Labeling Approved Letrozole ANDA #202716 Letrozole Tablet; Oral SUPPL-3 Jiangsu Hengrui Med Labeling Approved Mometasone Furoate ANDA #076624 Mometasone Furoate Ointment; Topical SUPPL-8 Taro Labeling Approved

 

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