CDER New: 8/3/2021

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 August 2, 2021 Competitive Generic Therapy Approvals (Updated) List of Determinations Including Written Request (Updated) FDA Drug Shortages Amitriptyline Hydrochloride Tablets (New - Discontinuation) 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. August 2, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Arthrotec NDA #020607 Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-39 Pfizer Labeling Approved Arthrotec NDA #020607 Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-39 Pfizer Labeling Approved Oriahnn (Copackaged) NDA #213388 Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium Capsule; Oral SUPPL-1 Abbvie Inc Labeling Approved July 30, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Arcapta Neohaler NDA #022383 Indacaterol Maleate Powder; Inhalation SUPPL-9 Novartis Labeling Approved Arcapta Neohaler NDA #022383 Indacaterol Maleate Powder; Inhalation SUPPL-10 Novartis Labeling Approved Istodax NDA #022393 Romidepsin Powder; Intravenous SUPPL-17 Celgene Efficacy Approved Pulmozyme BLA #103532 Dornase Alfa Vial SUPPL-5191 Genentech Labeling Approved Temozolomide ANDA #206750 Temozolomide Capsule; Oral SUPPL-2 Zydus Pharms Labeling Approved Temozolomide ANDA #206750 Temozolomide Capsule; Oral SUPPL-2 Zydus Pharms Labeling Approved Seebri NDA #207923 Glycopyrrolate Powder; Inhalation SUPPL-5 Novartis Labeling Approved Utibron NDA #207930 Glycopyrrolate; Indacaterol Maleate Powder; Inhalation SUPPL-5 Novartis Labeling Approved Utibron NDA #207930 Glycopyrrolate; Indacaterol Maleate Powder; Inhalation SUPPL-6 Novartis Labeling Approved Adlyxin BLA #208471 Lixisenatide Solution; Subcutaneous SUPPL-4 Sanofi-Aventis Us Efficacy Approved Micafungin Sodium NDA #212125 Micafungin Sodium Injectable; Intravenous ORIG-1 Teva Pharms Usa Type 5 - New Formulation or New Manufacturer Approved Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.225% In Plastic Container ANDA #212348 Dextrose; Potassium Chloride; Sodium Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa   Approved Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.225% In Plastic Container ANDA #212348 Dextrose; Potassium Chloride; Sodium Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa   Approved Saphnelo BLA #761123 Anifrolumab-Fnia Injectable; Injection ORIG-1 Astrazeneca Ab 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