CDER New: 5/25/2021

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 24, 2021 Public meeting on June 18, 2021: Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments (updated) CDER Small Business and Industry Assistance (SBIA) Learn (updated) Bispecific Antibody Development Programs Guidance for Industry FDA Drug Shortages Leuprolide Acetate Injection (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 23, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Yervoy BLA #125377 Ipilimumab Injectable; Injection SUPPL-121 Bristol Myers Squibb Efficacy Approved May 21, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Bactrim NDA #017560 Sulfamethoxazole; Trimethoprim Suspension; Oral SUPPL-45 Sun Pharm Industries Labeling Approved Bactrim Pediatric NDA #017560 Sulfamethoxazole; Trimethoprim Suspension; Oral SUPPL-45 Sun Pharm Industries Labeling Approved Bactrim NDA #018374 Sulfamethoxazole; Trimethoprim Injectable; Injection SUPPL-28 Sun Pharm Inds Inc Labeling Approved Axumin NDA #208054 Fluciclovine F-18 Solution; Intravenous SUPPL-34 Blue Earth Labeling Approved Ketoconazole ANDA #213601 Ketoconazole Aerosol, Foam; Topical ORIG-1 Xiromed   Approved Rybrevant BLA #761210 Amivantamab-Vmjw Injectable; Injection ORIG-1 Janssen Biotech 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