CDER New: 2/8/2021

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 February 5, 2021 FDA Drug Shortages Acetazolamide Injection (Updated - Currently in Shortage) Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage) Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage) Azacitidine for Injection (Updated - Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Diltiazem Hydrochloride Injection (Updated - Currently in Shortage) Enalaprilat Injection, USP (Updated - Currently in Shortage) Etomidate Injection (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) Ketamine Injection (Updated - Currently in Shortage) Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Lorazepam Injection, USP (Updated - Currently in Shortage) Methyldopa Tablets (Updated - Currently in Shortage) Midazolam Injection, USP (Updated - Currently in Shortage) Ondansetron Hydrochloride Injection (Updated - Currently in Shortage) Pantoprazole Sodium for Injection (Updated - Currently in Shortage) Promethazine (Phenergan) Injection (Updated - Currently in Shortage) Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage) Valproate Sodium Injection, USP (Updated - Currently in Shortage) Zinc Acetate Capsules (Updated - Currently in Shortage) Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated) GDUFA Reauthorization Sessions (updated) 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. February 5, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Librax NDA #012750 Chlordiazepoxide Hydrochloride; Clidinium Bromide Capsule; Oral SUPPL-67 Bausch Labeling Approved Klonopin NDA #017533 Clonazepam Tablet; Oral SUPPL-61 Roche Labeling Approved Klonopin NDA #017533 Clonazepam Tablet; Oral SUPPL-61 Roche Labeling Approved Ativan NDA #018140 Lorazepam Injectable; Injection SUPPL-46 Hikma Labeling Approved Diazepam NDA #020124 Diazepam Injectable; Injection SUPPL-33 Us Army Labeling Approved Diastat NDA #020648 Diazepam Gel; Rectal SUPPL-21 Bausch Labeling Approved Diastat Acudial NDA #020648 Diazepam Gel; Rectal SUPPL-21 Bausch Labeling Approved Onfi NDA #202067 Clobazam Tablet; Oral SUPPL-6 Lundbeck Pharms Llc Labeling Approved Onfi NDA #203993 Clobazam Suspension; Oral SUPPL-8 Lundbeck Pharms Llc Labeling Approved Seizalam NDA #209566 Midazolam Hydrochloride Solution; Intramuscular SUPPL-1 Meridian Medcl Techn Labeling Approved Biktarvy NDA #210251 Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-7 Gilead Sciences Inc Efficacy Approved Sympazan NDA #210833 Clobazam Film; Oral SUPPL-3 Aquestive Therap Labeling Approved Nayzilam NDA #211321 Midazolam Spray; Nasal SUPPL-5 Ucb Inc Labeling Approved Valtoco NDA #211635 Diazepam Spray; Nasal SUPPL-3 Neurelis Inc Labeling Approved Valtoco NDA #211635 Diazepam Spray; Nasal SUPPL-3 Neurelis Inc Labeling Approved Ukoniq NDA #213176 Umbralisib Tablet; Oral ORIG-1 Tg Therapeutics Inc Type 1 - New Molecular Entity Approved Ukoniq NDA #213176 Umbralisib Tablet; Oral ORIG-2 Tg Therapeutics Inc Type 1 - New Molecular Entity Approved February 4, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cyklokapron NDA #019281 Tranexamic Acid Injectable; Injection SUPPL-47 Pharmacia and Upjohn Labeling Approved Cyklokapron NDA #019281 Tranexamic Acid Injectable; Injection SUPPL-47 Pharmacia and Upjohn Labeling Approved Adrenaclick NDA #020800 Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-40 Impax Labeling Approved Twinject 0.15 NDA #020800 Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-40 Impax Labeling Approved Twinject 0.3 NDA #020800 Epinephrine Injectable; Intramuscular, Subcutaneous SUPPL-40 Impax Labeling Approved Carbidopa and Levodopa ANDA #074260 Carbidopa; Levodopa Tablet; Oral SUPPL-55 Actavis Elizabeth Labeling Approved Carbidopa and Levodopa ANDA #074260 Carbidopa; Levodopa Tablet; Oral SUPPL-55 Actavis Elizabeth Labeling Approved Sotalol Hydrochloride ANDA #075429 Sotalol Hydrochloride Tablet; Oral SUPPL-18 Teva Labeling Approved Sorine ANDA #075500 Sotalol Hydrochloride Tablet; Oral SUPPL-17 Upsher Smith Labs Labeling Approved Carbidopa and Levodopa ANDA #077120 Carbidopa; Levodopa Tablet; Oral SUPPL-7 Apotex Inc Labeling Approved Neupogen BLA #103353 Filgrastim Syringe SUPPL-5197 Amgen Labeling Approved Neupogen BLA #103353 Filgrastim Vial SUPPL-5197 Amgen Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #201633 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Sun Pharm Labeling Approved Buprenorphine Hydrochloride and Naloxone Hydrochloride ANDA #201633 Buprenorphine Hydrochloride; Naloxone Hydrochloride Tablet; Sublingual SUPPL-11 Sun Pharm Labeling Approved Oxymorphone Hydrochloride ANDA #202321 Oxymorphone Hydrochloride Tablet; Oral SUPPL-2 Specgx Llc Labeling Approved Oxymorphone Hydrochloride ANDA #202321 Oxymorphone Hydrochloride Tablet; Oral SUPPL-2 Specgx Llc Labeling Approved Neostigmine Methylsulfate NDA #203629 Neostigmine Methylsulfate Solution; Intravenous SUPPL-3 Fresenius Kabi Usa Labeling Approved Oseltamivir Phosphate ANDA #208348 Oseltamivir Phosphate Capsule; Oral SUPPL-7 Lupin Labeling Approved Oseltamivir Phosphate ANDA #208348 Oseltamivir Phosphate Capsule; Oral SUPPL-7 Lupin 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