CDER New: 4/29/2022

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Excluded Packages and Products Wholesale Distributor and Third-Party Logistics Providers Reporting April 28, 2022 Draft Guidance for Industry: Crohn's Disease: Developing Drugs for Treatment Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment April 27, 2022 CDER Conversations: Disclosing Information About Drugs and Fostering CDER's Transparency Efforts FDA Drug Shortages Dextrose 5% Injection (Updated - Currently in Shortage) Dobutamine Hydrochloride Injection (Updated - Currently in Shortage) Dopamine Hydrochloride Injection (Updated - Currently in Shortage) Ketorolac Tromethamine Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage) Lipid Injection (Updated - Currently in Shortage) Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage) Potassium Chloride Concentrate Injection (Updated - Currently in Shortage) Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage) Final Guidance for Industry: Providing Submissions in Electronic Format — Postmarketing Safety Reports 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. April 28, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cerebyx NDA #020450 Fosphenytoin Sodium Injectable; Injection SUPPL-46 Parke Davis Labeling Approved Opana Er NDA #021610 Oxymorphone Hydrochloride Tablet, Extended Release; Oral SUPPL-30 Endo Pharms Labeling Approved Ninlaro NDA #208462 Ixazomib Citrate Capsule; Oral SUPPL-12 Takeda Pharms Usa Efficacy Approved Ninlaro NDA #208462 Ixazomib Citrate Capsule; Oral SUPPL-13 Takeda Pharms Usa Labeling Approved Balversa NDA #212018 Erdafitinib Tablet; Oral SUPPL-3 Janssen Biotech Labeling Approved Camzyos NDA #214998 Mavacamten Capsule; Oral ORIG-1 Myokardia Inc Type 1 - New Molecular Entity Approved Cuvrior NDA #215760 Trientine Tetrahydrochloride Tablet; Oral ORIG-1 Orphalan Sa Type 2 - New Active Ingredient Approved Jemperli BLA #761174 Dostarlimab-Gxly Injectable; Injection SUPPL-2 Glaxosmithkline Labeling Approved April 27, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Idamycin NDA #050661 Idarubicin Hydrochloride Injectable; Injection SUPPL-17 Pfizer Labeling Approved Idamycin Pfs NDA #050734 Idarubicin Hydrochloride Injectable; Injection SUPPL-29 Pfizer Labeling Approved Epiduo Forte NDA #207917 Adapalene; Benzoyl Peroxide Gel; Topical SUPPL-4 Galderma Labs Labeling Approved Epiduo Forte NDA #207917 Adapalene; Benzoyl Peroxide Gel; Topical SUPPL-8 Galderma Labs Labeling Approved Epclusa NDA #208341 Sofosbuvir; Velpatasvir Tablet; Oral SUPPL-19 Gilead Sciences Inc Efficacy Approved Balversa NDA #212018 Erdafitinib Tablet; Oral SUPPL-2 Janssen Biotech Labeling Approved Epclusa NDA #214187 Sofosbuvir; Velpatasvir Pellets; Oral SUPPL-1 Gilead Sciences Inc Efficacy Approved Ultomiris BLA #761108 Ravulizumab-Cwvz Injectable; Injection SUPPL-23 Alexion Pharm Efficacy Approved April 26, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Evomela NDA #207155 Melphalan Hydrochloride Powder; Intravenous SUPPL-5 Acrotech Labeling Approved Triptodur Kit NDA #208956 Triptorelin Pamoate For Suspension, Extended Release; Intramuscular SUPPL-10 Arbor Pharms Llc Labeling Approved Caplyta NDA #209500 Lumateperone Tosylate Capsule; Oral SUPPL-9 Intra-Cellular Manufacturing (CMC) Approved Fensolvi Kit NDA #213150 Leuprolide Acetate Powder; Subcutaneous SUPPL-2 Tolmar Labeling Approved Vivjoa NDA #215888 Oteseconazole Capsule; Oral ORIG-1 Mycovia Pharmaceuticals 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