CDER New: 5/25/2022

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, 2022 Final Guidance for Industry: Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide May 24, 2022 Draft Guidance for Industry: Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1) Drugs@FDA Data Files (updated) FDA Drug Shortages Dextrose 5% Injection (Updated - Currently in Shortage) Diflunisal Tablets (Updated - Currently in Shortage) Fluvoxamine ER Capsules (Updated - Currently in Shortage) Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage) Sodium Chloride 0.9% Injection Bags (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 24, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Oxistat NDA #020209 Oxiconazole Nitrate Lotion; Topical SUPPL-14 Ani Pharms Labeling Approved Revlimid NDA #021880 Lenalidomide Capsule; Oral SUPPL-65 Celgene Labeling Approved May 23, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Tyvaso Dpi NDA #214324 Treprostinil Powder; Inhalation ORIG-1 United Therap Type 5 - New Formulation or New Manufacturer Approved Vtama NDA #215272 Tapinarof Cream; Topical ORIG-1 Dermavant Sciences Inc Type 1 - New Molecular Entity 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