CDER New: 11/30/2020

What's New Related to Drugs Updated Monday through Friday: Drug Firm Annual Registration Status Drug Firm Annual Registration Status Download File National Drug Code Directory NDC Unfinished Drugs Excluded Database File NDC Database Excluded Packages and Products Wholesale Distributor and Third-Party Logistics Providers Reporting November 27, 2020 FDA approves first treatment for weight management for people with certain rare genetic conditions Recent New and Generic Drug Approvals This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA. November 27, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Prevacid NDA #020406 Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved Prevacid NDA #020406 Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved Aciphex NDA #020973 Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-41 Eisai Inc Labeling Approved Protonix NDA #020987 Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-56 Wyeth Pharms Labeling Approved Protonix Iv NDA #020988 Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-62 Wyeth Pharms Labeling Approved Nexium NDA #021153 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-57 Astrazeneca Pharms Labeling Approved Prevacid NDA #021428 Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved Prevacid NDA #021428 Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved Finacea NDA #021470 Azelaic Acid Gel; Topical SUPPL-15 Leo Pharma As Labeling Approved Finacea NDA #021470 Azelaic Acid Gel; Topical SUPPL-16 Leo Pharma As Labeling Approved Zegerid NDA #021636 Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-22 Salix Labeling Approved Nexium Iv NDA #021689 Esomeprazole Sodium Injectable; Intravenous SUPPL-35 Astrazeneca Pharms Labeling Approved Zegerid NDA #021849 Omeprazole; Sodium Bicarbonate Capsule; Oral SUPPL-16 Salix Labeling Approved Nexium NDA #021957 Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-24 Astrazeneca Pharms Labeling Approved Protonix NDA #022020 Pantoprazole Sodium For Suspension, Delayed Release; Oral SUPPL-18 Wyeth Pharms Labeling Approved Prilosec NDA #022056 Omeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-23 Covis Pharma Bv Labeling Approved Nexium NDA #022101 Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-21 Astrazeneca Pharms Labeling Approved Dexilant NDA #022287 Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved Dexilant NDA #022287 Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved Vimovo NDA #022511 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-25 Horizon Labeling Approved Omeprazole and Clarithromycin and Amoxicillin NDA #050824 Amoxicillin; Clarithromycin; Omeprazole Capsule, Tablet, Capsule, Delayed Release; Oral SUPPL-9 Cumberland Pharms Labeling Approved Fluconazole In Sodium Chloride 0.9% ANDA #076087 Fluconazole Injectable; Injection SUPPL-16 West-Ward Pharms Int Labeling Approved Teflaro NDA #200327 Ceftaroline Fosamil Powder; Intravenous SUPPL-25 Allergan Labeling Approved Esomeprazole Strontium NDA #202342 Esomeprazole Strontium Capsule, Delayed Release; Oral SUPPL-6 Belcher Labeling Approved Aciphex Sprinkle NDA #204736 Rabeprazole Sodium Capsule, Delayed Release; Oral SUPPL-12 Aytu Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved Pantoprazole Sodium NDA #209463 Pantoprazole Sodium Powder; Iv (Infusion) SUPPL-11 Hikma Labeling Approved Talicia NDA #213004 Amoxicillin; Omeprazole Magnesium; Rifabutin Capsule, Delayed Release; Oral SUPPL-2 Redhill Labeling Approved November 25, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Sildenafil Citrate ANDA #202506 Sildenafil Citrate Tablet; Oral ORIG-1 Watson Labs Inc   Approved Jynarque NDA #204441 Tolvaptan Tablet; Oral SUPPL-9 Otsuka Pharm Co Ltd REMS Approved Azelastine Hydrochloride and Fluticasone Propionate ANDA #207712 Azelastine Hydrochloride; Fluticasone Propionate Spray, Metered; Nasal SUPPL-4 Apotex Manufacturing (CMC) Approved Testosterone ANDA #209181 Testosterone Solution, Metered; Transdermal ORIG-1 Apotex   Approved Gefitinib ANDA #209792 Gefitinib Unknown ORIG-1 Synthon Pharms   Tentative Approval Metoprolol Succinate ANDA #211143 Metoprolol Succinate Tablet, Extended Release; Oral ORIG-1 Alkem Labs Ltd   Approved Micafungin Sodium NDA #212125 Micafungin Sodium Unknown ORIG-1 Teva Pharms Usa Type 5 - New Formulation or New Manufacturer Tentative Approval Tavaborole ANDA #212256 Tavaborole Solution; Topical ORIG-1 Amneal   Approved Atenolol and Chlorthalidone ANDA #213302 Atenolol; Chlorthalidone Tablet; Oral ORIG-1 Unichem   Approved Guanfacine Hydrochloride ANDA #213428 Guanfacine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Yichang Humanwell   Approved Imcivree NDA #213793 Setmelanotide Solution; Subcutaneous ORIG-1 Rhythm Pharmaceuticals Inc Type 1 - New Molecular Entity Approved Danyelza BLA #761171 Naxitamab-Gqgk Solution; Intravenous ORIG-1 Y-Mabs Therapeutics Inc Type 1 - New Molecular Entity Approved Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA