CDER New: 4/1/2022

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 March 31, 2022 FDA Drug Shortages Dexmedetomidine Injection (Updated - Currently in Shortage) Semaglutide (WEGOVY®) Injection (New - Currently in Shortage) Online Verification of eCPPs for Human Drug Products 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. March 31, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Promacta NDA #022291 Eltrombopag Olamine Tablet; Oral SUPPL-33 Novartis Labeling Approved Promacta Kit NDA #207027 Eltrombopag Olamine For Suspension; Oral SUPPL-15 Novartis Labeling Approved March 30, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Furosemide NDA #018579 Furosemide Injectable; Injection SUPPL-33 Am Regent Manufacturing (CMC) Approved Furosemide NDA #018579 Furosemide Injectable; Injection SUPPL-33 Am Regent Manufacturing (CMC) Approved Triumeq NDA #205551 Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Tablet; Oral SUPPL-28 Viiv Hlthcare Efficacy Approved Tissueblue NDA #209569 Brilliant Blue G Solution; Ophthalmic SUPPL-4 Dutch Ophthalmic Labeling Approved Sodium Phosphates ANDA #209997 Sodium Phosphate, Dibasic, Heptahydrate; Sodium Phosphate, Monobasic, Anhydrous Injectable; Injection ORIG-1 Fresenius Kabi Usa   Approved Doxycycline Hyclate ANDA #212487 Doxycycline Hyclate Tablet; Oral ORIG-1 Praxgen   Approved Dolutegravir Lamivudine Tenofovir Alafenamide NDA #212527 Dolutegravir Lamivudine Tenofovir Alafenamide Tablet, For Suspension; Oral ORIG-1 Cipla Usa Inc. Type 4 - New Combination Tentative Approval Enalapril Maleate ANDA #213714 Enalapril Maleate Solution; Oral ORIG-1 Alkem Labs Ltd   Approved Ioflupane I-123 ANDA #213792 Ioflupane I-123 Solution; Intravenous ORIG-1 Curium   Approved Ibuprofen ANDA #215318 Ibuprofen Tablet; Oral ORIG-1 Yichang Humanwell   Approved Triumeq Pd NDA #215413 Abacavir Dolutegravir Lamivudine Tablet, For Suspension; Oral ORIG-1 Viiv Hlthcare Type 3 - New Dosage Form Approved Poteligeo BLA #761051 Mogamulizumab-Kpkc Injectable; Injection SUPPL-15 Kyowa Kirin Labeling 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