CDER New: 7/19/2021

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 July 16, 2021 FDA Approves New Use of Transplant Drug Based on Real-World Evidence FDA approves belumosudil for chronic graft-versus-host disease 2021 Compounding Quality Center of Excellence Virtual Conference: Culture of Quality - 09/14/2021 - 09/15/2021 FDA Drug Shortages Bumetanide Injection (Updated - Currently in Shortage) Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage) Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage) Dobutamine Hydrochloride Injection (Updated - Currently in Shortage) Dopamine Hydrochloride Injection (Updated - Currently in Shortage) Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) Furosemide Injection (Updated - Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Hydrocortisone Tablets (Updated - Currently in Shortage) Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage) Ketamine Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage) Lorazepam Injection (Updated - Currently in Shortage) Midazolam Injection Updated - Currently in Shortage) Misoprostol Tablets (Updated - Currently in Shortage) Morphine Sulfate Injection (Updated - Currently in Shortage) Ondansetron Hydrochloride Injection (Updated - Currently in Shortage) Pantoprazole Sodium for Injection (Updated - Currently in Shortage) Potassium Acetate Injection (Updated - Currently in Shortage) Propofol Injectable Emulsion (Updated - Currently in Shortage) Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage) Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage) Sulfasalazine Tablets (Updated - Currently in Shortage) Varenicline Tartrate (Chantix) Tablets (New - 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. July 16, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Prograf NDA #050708 Tacrolimus Capsule; Oral SUPPL-53 Astellas Efficacy Approved Prograf NDA #050709 Tacrolimus Injectable; Injection SUPPL-45 Astellas Efficacy Approved Prograf NDA #210115 Tacrolimus For Suspension; Oral SUPPL-5 Astellas Efficacy Approved Fexinidazole NDA #214429 Fexinidazole Tablet; Oral ORIG-1 Drugs For Neglected Diseases Initiative Type 1 - New Molecular Entity Approved Rezurock NDA #214783 Belumosudil Tablet; Oral ORIG-1 Kadmon Pharma Llc Type 1 - New Molecular Entity Approved July 15, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Flo-Pred NDA #022067 Prednisolone Acetate Suspension; Oral SUPPL-14 Taro Labeling Approved Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-99 Bristol Myers Squibb Efficacy Approved Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-99 Bristol Myers Squibb Efficacy Approved Diclofenac Sodium and Misoprostol ANDA #204355 Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral ORIG-1 Micro Labs   Approved Anjeso NDA #210583 Meloxicam Solution; Intravenous SUPPL-2 Baudax Labeling Approved Gvoke Hypopen NDA #212097 Glucagon Solution; Subcutaneous SUPPL-8 Xeris Labeling Approved Gvoke Pfs NDA #212097 Glucagon Solution; Subcutaneous SUPPL-8 Xeris Labeling Approved Estradiol ANDA #212313 Estradiol Cream; Vaginal ORIG-1 Prasco Labs Llc   Approved Tobramycin and Dexamethasone ANDA #212991 Dexamethasone; Tobramycin Suspension/Drops; Ophthalmic ORIG-1 Amneal   Approved Mesalamine ANDA #214242 Mesalamine Capsule, Extended Release; Oral ORIG-1 Alkem Labs Ltd   Approved Pregabalin ANDA #214322 Pregabalin Capsule; Oral ORIG-1 Changzhou Pharm   Approved Imfinzi BLA #761069 Durvalumab Injectable; Injection SUPPL-28 Astrazeneca Uk Ltd 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