CDER New: 5/26/2021

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 May 25, 2021 Drugs@FDA Data Files (updated) FDA Drug Shortages Rifampin Injection (Updated - Currently in Shortage) Medical Imaging Drugs Advisory Committee Charter   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. May 25, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Zipsor NDA #022202 Diclofenac Potassium Capsule; Oral SUPPL-13 Assertio Efficacy Approved Zipsor NDA #022202 Diclofenac Potassium Capsule; Oral SUPPL-14 Assertio Labeling Approved Yervoy BLA #125377 Ipilimumab Injectable; Injection SUPPL-121 Bristol Myers Squibb Efficacy Approved Fingolimod Hydrochloride ANDA #207939 Fingolimod Hydrochloride Capsule; Oral ORIG-1 Hec Pharm Co Ltd   Tentative Approval Ameluz NDA #208081 Aminolevulinic Acid Hydrochloride Gel; Topical SUPPL-11 Biofrontera Labeling Approved Barhemsys NDA #209510 Amisulpride Solution; Intravenous SUPPL-3 Acacia Labeling Approved May 24, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Vancocin Hydrochloride ANDA #062476 Vancomycin Hydrochloride Injectable; Injection SUPPL-28 Ani Pharms Labeling Approved Vancomycin Hydrochloride ANDA #062663 Vancomycin Hydrochloride Injectable; Injection SUPPL-94 Fresenius Kabi Usa Labeling Approved Vancocin Hydrochloride ANDA #062716 Vancomycin Hydrochloride Injectable; Injection SUPPL-21 Ani Pharms Labeling Approved Vancocin Hydrochloride ANDA #062812 Vancomycin Hydrochloride Injectable; Injection SUPPL-34 Ani Pharms Labeling Approved Vancomycin Hydrochloride ANDA #062911 Vancomycin Hydrochloride Injectable; Injection SUPPL-61 Hospira Labeling Approved Vancomycin Hydrochloride ANDA #062912 Vancomycin Hydrochloride Injectable; Injection SUPPL-81 Hospira Labeling Approved Vancomycin Hydrochloride ANDA #062931 Vancomycin Hydrochloride Injectable; Injection SUPPL-43 Hospira Labeling Approved Vancomycin Hydrochloride ANDA #062933 Vancomycin Hydrochloride Injectable; Injection SUPPL-50 Hospira Labeling Approved Vancomycin Hydrochloride ANDA #063076 Vancomycin Hydrochloride Injectable; Injection SUPPL-43 Hospira Labeling Approved Vancomycin Hydrochloride ANDA #065455 Vancomycin Hydrochloride Injectable; Injection SUPPL-18 Hospira Inc Labeling Approved Cyanocobalamin ANDA #080737 Cyanocobalamin Injectable; Injection SUPPL-40 Am Regent Manufacturing (CMC) Approved Xtandi NDA #213674 Enzalutamide Tablet; Oral SUPPL-2 Astellas Labeling 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