CDER New: 9/20/2021

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 September 17, 2021 Competitive Generic Therapy Approvals (Updated) FDA Drug Alert: FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy Guidance for Industry: Questions and Answers on Biosimilar Development and the BPCI Act New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)  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. September 16, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Climara NDA #020375 Estradiol Film, Extended Release; Transdermal SUPPL-45 Bayer Hlthcare Labeling Approved Climara NDA #020375 Estradiol Film, Extended Release; Transdermal SUPPL-46 Bayer Hlthcare Labeling Approved Menostar NDA #020375 Estradiol Film, Extended Release; Transdermal SUPPL-45 Bayer Hlthcare Labeling Approved Menostar NDA #020375 Estradiol Film, Extended Release; Transdermal SUPPL-46 Bayer Hlthcare Labeling Approved Optison NDA #020899 Albumin Human Injectable; Injection SUPPL-24 Ge Healthcare Labeling Approved September 15, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Vimpat NDA #022253 Lacosamide Tablet; Oral SUPPL-51 Ucb Inc Labeling Approved Vimpat NDA #022254 Lacosamide Solution; Intravenous SUPPL-41 Ucb Inc Labeling Approved Vimpat NDA #022255 Lacosamide Solution; Oral SUPPL-33 Ucb Inc Labeling Approved Mycobutin NDA #050689 Rifabutin Capsule; Oral SUPPL-26 Pfizer Labeling Approved Cefuroxime Axetil ANDA #065359 Cefuroxime Axetil Tablet; Oral SUPPL-10 Orchid Hlthcare Labeling Approved Alprazolam ANDA #074112 Alprazolam Tablet; Oral SUPPL-36 Sandoz Labeling Approved Alprazolam ANDA #074112 Alprazolam Tablet; Oral SUPPL-36 Sandoz Labeling Approved Oxybutynin Chloride ANDA #075079 Oxybutynin Chloride Tablet; Oral SUPPL-21 Vintage Pharms Manufacturing (CMC) Approved Metoprolol Tartrate ANDA #091045 Metoprolol Tartrate Injectable; Injection SUPPL-3 Fresenius Kabi Usa Labeling Approved Descovy NDA #208215 Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-19 Gilead Sciences Inc Labeling Approved Vemlidy NDA #208464 Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-13 Gilead Sciences Inc Labeling Approved Kisqali NDA #209092 Ribociclib Succinate Tablet; Oral SUPPL-9 Novartis Labeling Approved Kisqali Femara Co-Pack (Copackaged) NDA #209935 Letrozole; Ribociclib Succinate Tablet; Oral SUPPL-13 Novartis Labeling Approved Dalfampridine ANDA #210158 Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Micro Labs Labeling Approved Dalfampridine ANDA #210158 Dalfampridine Tablet, Extended Release; Oral SUPPL-4 Micro Labs Labeling Approved Exkivity NDA #215310 Mobocertinib Capsule; Oral ORIG-1 Takeda Pharms Usa 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