CDER New: 5/7/2021

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 6, 2021 DDT COA #000148: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D) FDA Drug Shortages Loxapine Capsules (Updated - Currently in Shortage) Sodium Bicarbonate Injection (Updated - Currently in Shortage) Triamcinolone Hexacetonide Injectable suspension (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. May 6, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Onpattro NDA #210922 Patisiran Sodium Solution; Intravenous SUPPL-9 Alnylam Pharms Inc Labeling Approved May 5, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ganciclovir Sodium ANDA #076222 Ganciclovir Sodium Injectable; Injection SUPPL-6 West-Ward Pharms Int Labeling Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-97 Merck Sharp Dohme Efficacy Approved Iressa NDA #206995 Gefitinib Tablet; Oral SUPPL-4 Astrazeneca Labeling Approved Daptomycin NDA #209949 Daptomycin Powder; Iv (Infusion) SUPPL-6 Xellia Pharms Aps Efficacy Approved Daptomycin NDA #209949 Daptomycin Powder; Iv (Infusion) SUPPL-7 Xellia Pharms Aps Efficacy Approved Upneeq NDA #212520 Oxymetazoline Hydrochloride Solution/Drops; Ophthalmic SUPPL-4 Rvl Pharms Labeling Approved Droxidopa ANDA #214543 Droxidopa Capsule; Oral ORIG-1 Bluepharma   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