CDER New: 1/29/2021

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 January 28, 2021 Laboratory analysis of rifampin/rifapentine products Drug Shortages  Adapalene/Benzoyl Peroxide Topical Gel (New - Discontinuation) Cisatracurium Besylate Injection (Updated - Currently in Shortage) Cefazolin Injection (Updated - Currently in Shortage) Dexmedetomidine Injection (Updated - Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Multi-Vitamin Infusion (Adult and Pediatric) (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. January 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Nplate BLA #125268 Romiplostim Injectable; Subcutaneous SUPPL-167 Amgen Efficacy Approved Rapivab NDA #206426 Peramivir Solution; Intravenous SUPPL-7 Biocryst Efficacy Approved January 27, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Diphenoxylate Hydrochloride and Atropine Sulfate ANDA #211362 Atropine Sulfate; Diphenoxylate Hydrochloride Tablet; Oral ORIG-1 Winder Labs Llc   Approved Amphetamine Sulfate ANDA #212186 Amphetamine Sulfate Tablet; Oral ORIG-1 Glenmark Pharms Ltd   Approved Amphetamine Sulfate ANDA #214574 Amphetamine Sulfate Tablet; Oral ORIG-1 Sun Pharm Inds Inc   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