CDER New: 7/28/2021

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 July 28, 2021 FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide) (new) July 27, 2021 Drugs@FDA Data Files (updated) FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer FDA Drug Shortages Cisatracurium Besylate Injection (Updated - Resolved)  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. July 27, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Zejula NDA #208447 Niraparib Tosylate Capsule; Oral SUPPL-22 Glaxosmithkline Labeling Approved Zejula NDA #208447 Niraparib Tosylate Capsule; Oral SUPPL-24 Glaxosmithkline Labeling Approved July 26, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Milrinone Lactate In Dextrose 5% In Plastic Container ANDA #075885 Milrinone Lactate Injectable; Injection SUPPL-20 Hospira Labeling Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-89 Merck Sharp Dohme Efficacy Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-114 Merck Sharp Dohme Efficacy Approved Zarxio BLA #125553 Filgrastim-Sndz Injectable; Injection SUPPL-23 Sandoz Inc Labeling Approved Zarxio BLA #125553 Filgrastim-Sndz Injectable; Injection SUPPL-23 Sandoz Inc Labeling Approved Tagrisso NDA #208065 Osimertinib Mesylate Tablet; Oral SUPPL-22 Astrazeneca Labeling Approved Idhifa NDA #209606 Enasidenib Mesylate Tablet; Oral SUPPL-5 Celgene Corp Manufacturing (CMC) Approved Apixaban ANDA #209845 Apixaban Tablet; Oral ORIG-1 Breckenridge   Approved Sapropterin Dihydrochloride ANDA #210027 Sapropterin Dihydrochloride Powder; Oral SUPPL-4 Par Pharm Inc Labeling Approved Erythromycin ANDA #211975 Erythromycin Tablet, Delayed Release; Oral ORIG-1 Torrent   Approved Atropine Sulfate ANDA #212868 Atropine Sulfate Solution; Intravenous ORIG-1 Accord Hlthcare   Approved Haloperidol Decanoate ANDA #214507 Haloperidol Decanoate Injectable; Injection ORIG-1 Hong Kong   Approved Twyneo NDA #214902 Tretinoin;Benzoyl Peroxide Cream; Topical ORIG-1 Sol-Gel Technologies Ltd Type 4 - New Combination 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