CDER New: 4/9/2021

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 April 8, 2021 Patent Certifications and Suitability Petitions (updated) Search List of Extended Use Dates to Assist with Drug Shortages (update) FDA Drug Shortages Vardenafil Hydrochloride Tablets (New - Discontinuation) Acetazolamide Injection (Updated - Currently in Shortage) Atropine Sulfate Injection (Updated - Currently in Shortage) Azacitidine for Injection (Updated - Currently in Shortage) Bumetanide Injection, USP (Updated - Currently in Shortage) Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage) Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage) Cisatracurium Besylate InjectionAcetazolamide Injection (Updated - Currently in Shortage) Atropine Sulfate Injection (Updated - Currently in Shortage) Azacitidine for Injection (Updated - Currently in Shortage) Bumetanide Injection, USP (Updated - Currently in Shortage) Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage) Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage) Cisatracurium Besylate Injection (Updated - Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Dexmedetomidine Injection (Updated - Currently in Shortage) Dobutamine Hydrochloride Injection (Updated - Currently in Shortage) Dopamine Hydrochloride Injection (Updated - Currently in Shortage) Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Hydromorphone Hydrochloride Injection, USP (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, USP (Updated - Currently in Shortage) Midazolam Injection, USP (Updated - Currently in Shortage) Misoprostol Tablets (Updated - Currently in Shortage) Ondansetron Hydrochloride Injection (Updated - Currently in Shortage) Pantoprazole Sodium for 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) Valproate Sodium Injection, USP (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. April 8, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ztlido NDA #207962 Lidocaine Patch; Topical SUPPL-5 Scilex Pharms Inc Efficacy Approved Byfavo NDA #212295 Remimazolam Besylate Powder; Intravenous SUPPL-2 Acacia Labeling Approved April 7, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ketamine Hydrochloride ANDA #074524 Ketamine Hydrochloride Injectable; Injection SUPPL-18 West-Ward Pharms Int Labeling Approved Rizatriptan Benzoate ANDA #078173 Rizatriptan Benzoate Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Pharms Inc Labeling Approved Rizatriptan Benzoate ANDA #078173 Rizatriptan Benzoate Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Pharms Inc Labeling Approved Rizatriptan Benzoate ANDA #078173 Rizatriptan Benzoate Tablet, Orally Disintegrating; Oral SUPPL-7 Mylan Pharms Inc Labeling Approved Vancomycin Hydrochloride ANDA #091554 Vancomycin Hydrochloride Injectable; Injection SUPPL-14 Mylan Labs Ltd Labeling Approved Vancomycin Hydrochloride ANDA #091554 Vancomycin Hydrochloride Injectable; Injection SUPPL-15 Mylan Labs Ltd Labeling Approved Vilazodone Hydrochloride ANDA #208200 Vilazodone Hydrochloride Tablet; Oral ORIG-1 Invagen Pharms   Approved Vilazodone Hydrochloride ANDA #208200 Vilazodone Hydrochloride Tablet; Oral ORIG-2 Invagen Pharms   Tentative Approval Teriflunomide ANDA #209638 Teriflunomide Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd Labeling Approved Teriflunomide ANDA #209638 Teriflunomide Tablet; Oral SUPPL-4 Aurobindo Pharma Ltd Labeling Approved Teriflunomide ANDA #209663 Teriflunomide Tablet; Oral SUPPL-3 Glenmark Pharms Labeling Approved Vancomycin Hydrochloride ANDA #212332 Vancomycin Hydrochloride Injectable; Injection SUPPL-3 Hainan Poly Pharm Labeling Approved Trodelvy BLA #761115 Sacituzumab Govitecan-Hziy Injectable; Injection SUPPL-5 Immunomedics Inc Efficacy Approved Trodelvy BLA #761115 Sacituzumab Govitecan-Hziy Injectable; Injection SUPPL-13 Immunomedics Inc Efficacy 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