CDER New: 6/4/2021

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 June 3, 2021 Comunicaciones de la FDA sobre la seguridad de los medicamentos: Debido al riesgo de lesión hepática grave, la FDA restringe el uso de Ocaliva (ácido obeticólico) en pacientes con colangitis biliar primaria (CBP) con cirrosis avanzada Manual of Policies and Procedures (MAPP) 5021.2 Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAs Guidance for Industry: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers FDA Drug Safety Podcast: Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis 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) Cisatracurium Besylate Injection (Updated - Currently in Shortage) Dexmedetomidine Injection (Updated - Currently in Shortage) Dobutamine Hydrochloride Injection (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) 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) Nalbuphine Hydrochloride Injection (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) Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage) Sulfasalazine Tablets (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. June 3, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Betapace NDA #019865 Sotalol Hydrochloride Tablet; Oral SUPPL-22 Covis Labeling Approved Triglide NDA #021350 Fenofibrate Tablet; Oral SUPPL-23 Skyepharma Ag Labeling Approved Lipofen NDA #021612 Fenofibrate Capsule; Oral SUPPL-24 Cipher Pharms Inc Labeling Approved Tricor NDA #021656 Fenofibrate Tablet; Oral SUPPL-30 Abbvie Labeling Approved Tricor NDA #021656 Fenofibrate Tablet; Oral SUPPL-31 Abbvie Labeling Approved Antara (Micronized) NDA #021695 Fenofibrate Capsule; Oral SUPPL-22 Lupin Labeling Approved Fenoglide NDA #022118 Fenofibrate Tablet; Oral SUPPL-13 Salix Labeling Approved Trilipix NDA #022224 Choline Fenofibrate Capsule, Delayed Release; Oral SUPPL-16 Abbvie Labeling Approved Trilipix NDA #022224 Choline Fenofibrate Capsule, Delayed Release; Oral SUPPL-17 Abbvie Labeling Approved Fibricor NDA #022418 Fenofibric Acid Tablet; Oral SUPPL-19 Athena Labeling Approved Reyvow NDA #211280 Lasmiditan Succinate Tablet; Oral SUPPL-5 Eli Lilly and Co Labeling Approved June 2, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Dolophine Hydrochloride NDA #006134 Methadone Hydrochloride Syrup; Oral SUPPL-50 Hikma Labeling Approved Dolophine Hydrochloride NDA #006134 Methadone Hydrochloride Tablet; Oral SUPPL-50 Hikma Labeling Approved Methadone Hydrochloride NDA #017058 Methadone Hydrochloride Tablet, For Suspension; Oral SUPPL-27 Hikma Labeling Approved Methadose NDA #017116 Methadone Hydrochloride Concentrate; Oral SUPPL-41 Specgx Llc Labeling Approved Methadone Hydrochloride NDA #021624 Methadone Hydrochloride Injectable; Injection SUPPL-14 Mylan Institutional Labeling Approved Morphine Sulfate NDA #022195 Morphine Sulfate Solution; Oral SUPPL-10 Hikma Efficacy Approved Morphine Sulfate NDA #022207 Morphine Sulfate Tablet; Oral SUPPL-5 Hikma Efficacy Approved Raxibacumab BLA #125349 Raxibacumab Injectable; Iv (Infusion) SUPPL-26 Human Genome Sciences Inc. Labeling Approved Methadone Hydrochloride ANDA #203502 Methadone Hydrochloride Tablet; Oral SUPPL-8 Aurolife Pharma Llc Labeling Approved Methadone Hydrochloride ANDA #203502 Methadone Hydrochloride Tablet; Oral SUPPL-8 Aurolife Pharma Llc Labeling Approved Akynzeo NDA #205718 Netupitant; Palonosetron Hydrochloride Capsule; Oral SUPPL-9 Helsinn Hlthcare Labeling Approved Morphine Sulfate ANDA #207270 Morphine Sulfate Tablet; Oral ORIG-1 Mayne Pharma Inc   Approved Methadone Hydrochloride ANDA #208305 Methadone Hydrochloride Tablet; Oral SUPPL-5 Sun Pharm Industries Labeling Approved Methadone Hydrochloride ANDA #208305 Methadone Hydrochloride Tablet; Oral SUPPL-5 Sun Pharm Industries Labeling Approved Methadone Hydrochloride ANDA #210484 Methadone Hydrochloride Tablet; Oral SUPPL-6 Nostrum Labs Inc Labeling Approved Methadone Hydrochloride ANDA #210484 Methadone Hydrochloride Tablet; Oral SUPPL-6 Nostrum Labs Inc Labeling Approved Akynzeo NDA #210493 Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride Powder; Intravenous SUPPL-4 Helsinn Hlthcare Labeling Approved Akynzeo NDA #210493 Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride Solution; Intravenous SUPPL-4 Helsinn Hlthcare Labeling Approved Methadone Hydrochloride ANDA #211228 Methadone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc Labeling Approved Methadone Hydrochloride ANDA #211228 Methadone Hydrochloride Tablet; Oral SUPPL-2 Ascent Pharms Inc Labeling Approved Micafungin Sodium ANDA #211713 Micafungin Sodium Injectable; Intravenous ORIG-1 Xellia Pharms Aps   Approved Oxycodone Hydrochloride ANDA #213761 Oxycodone Hydrochloride Solution; Oral ORIG-1 Quagen   Approved Chlorpromazine Hydrochloride ANDA #214542 Chlorpromazine Hydrochloride Concentrate; Oral ORIG-1 Genus   Approved Monjuvi (Tafasitamab-Cxix) For Injection BLA #761163 Tafasitamab-Cxix Injectable; Injection SUPPL-1 Morphosys Us Inc Labeling Approved Monjuvi (Tafasitamab-Cxix) For Injection BLA #761163 Tafasitamab-Cxix Injectable; Injection SUPPL-1 Morphosys Us Inc 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