CDER New: 8/20/2021

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 19, 2021 Advancing Our Understanding of How Drug Promotion Influences Consumers and Health Care Providers (new) FDA Drug Shortages Fluvoxamine ER Capsules (Updated - Currently in Shortage) Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage) Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage) Loxapine Capsules (Updated - Currently in Shortage) Nizatidine Capsules (Updated - Currently in Shortage) Propofol Injectable Emulsion (Updated - Currently in Shortage) 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 19, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-97 Bristol Myers Squibb Efficacy Approved Uptravi NDA #207947 Selexipag Tablet; Oral SUPPL-10 Actelion Labeling Approved Uptravi NDA #207947 Selexipag Tablet; Oral SUPPL-10 Actelion Labeling Approved August 18, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ventolin Hfa NDA #020983 Albuterol Sulfate Aerosol, Metered; Inhalation SUPPL-41 Glaxosmithkline Labeling Approved Advair Hfa NDA #021254 Fluticasone Propionate; Salmeterol Xinafoate Aerosol, Metered; Inhalation SUPPL-36 Glaxo Grp Ltd Labeling Approved Flovent Hfa NDA #021433 Fluticasone Propionate Aerosol, Metered; Inhalation SUPPL-40 Glaxo Grp Ltd Labeling Approved Ethosuximide ANDA #040686 Ethosuximide Capsule; Oral SUPPL-12 Akorn Labeling Approved Pravastatin Sodium ANDA #077013 Pravastatin Sodium Tablet; Oral SUPPL-4 Mylan Labeling Approved Famotidine ANDA #077351 Famotidine Tablet; Oral SUPPL-28 Perrigo R and D Manufacturing (CMC) Approved Bupropion Hydrochloride ANDA #077475 Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-20 Sandoz Inc Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5183 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5183 Genzyme Labeling Approved Jardiance NDA #204629 Empagliflozin Tablet; Oral SUPPL-26 Boehringer Ingelheim Efficacy Approved Brinzolamide ANDA #204884 Brinzolamide Suspension/Drops; Ophthalmic ORIG-1 Bausch   Approved Lexette NDA #210566 Halobetasol Propionate Aerosol, Foam; Topical SUPPL-3 Mayne Pharma Efficacy Approved Labetalol Hydrochloride ANDA #211953 Labetalol Hydrochloride Tablet; Oral ORIG-1 Rubicon   Approved Palbociclib ANDA #213091 Palbociclib Unknown ORIG-1 Dr Reddys Labs Ltd   Tentative Approval 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