CDER New: 3/16/2021

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 March 15, 2021 FDA Drug Shortages Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage) Cefotetan Disodium Injection (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) Furosemide Injection, USP (Updated - Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Hydralazine Hydrochloride Injection, USP (Updated - Currently in Shortage) Hydromorphone Hydrochloride Injection, USP (New - Currently in Shortage) Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage) Ketorolac Tromethamine Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage) Midazolam Injection, USP (Updated - Currently in Shortage) Morphine Sulfate Injection (Updated - Currently in Shortage) Ondansetron Hydrochloride Injection (Updated - Currently in Shortage) Oxytocin Injection, USP Synthetic (Updated - Currently in Shortage) Propofol Injectable Emulsion (Updated - Currently in Shortage) Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage) Sertraline Hydrochloride Oral Solution, USP (Updated - Currently in Shortage) Sertraline Hydrochloride Tablets (Updated - Resolved) Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage) Sodium Chloride 23.4% Injection (Updated - Currently in Shortage) Sodium Chloride Injection USP, 0.9% Vials and Syringes (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. March 15, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Radicava NDA #209176 Edaravone Solution; Intravenous SUPPL-10 Mitsubishi Tanabe Labeling Approved March 12, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Elmiron NDA #020193 Pentosan Polysulfate Sodium Capsule; Oral SUPPL-15 Janssen Pharms Labeling Approved Elmiron NDA #020193 Pentosan Polysulfate Sodium Capsule; Oral SUPPL-15 Janssen Pharms Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5180 Genzyme REMS Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5180 Genzyme REMS Approved Carmustine ANDA #211202 Carmustine Injectable; Injection ORIG-1 Jiangsu Hengrui Med   Approved Lincomycin Hydrochloride ANDA #212770 Lincomycin Hydrochloride Injectable; Injection ORIG-1 Praxgen   Approved Lacosamide ANDA #214672 Lacosamide Unknown ORIG-1 Alkem Labs Ltd   Tentative Approval Sirolimus ANDA #214753 Sirolimus Tablet; Oral ORIG-1 Alkem Labs Ltd   Approved Darzalex BLA #761036 Daratumumab Injectable; Injection SUPPL-33 Janssen Biotech Labeling Approved Ziextenzo BLA #761045 Pegfilgrastim-Bmez Injectable; Injection SUPPL-6 Sandoz Inc Labeling Approved Ziextenzo BLA #761045 Pegfilgrastim-Bmez Injectable; Injection SUPPL-6 Sandoz Inc Labeling Approved Darzalex Faspro BLA #761145 Daratumumab;Hyaluronidase-Fihj Injectable; Injection SUPPL-5 Janssen Biotech 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