CDER New: 9/1/2021

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 August 31, 2021 CDER Manual of Policies and Procedures (MAPP) 5100.4 Rev.1 Scientific Interest Groups: Criteria and Policies 7610.7 Rev.1 CDER Data Standards Program Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) Guidance for Industry Generic Drug Research Collaboration Opportunities (updated) GDUFA III Reauthorization Negotiation Sessions (updated) What's New in Regulatory Science (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. August 31, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Keytruda BLA #125514 Pembrolizumab Solution; Intravenous SUPPL-117 Merck Sharp Dohme Efficacy Approved Keytruda BLA #125514 Pembrolizumab Solution; Intravenous SUPPL-118 Merck Sharp Dohme Efficacy Approved August 30, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Sutent NDA #021938 Sunitinib Malate Capsule; Oral SUPPL-39 Cppi Cv Efficacy Approved Fluoxetine Hydrochloride ANDA #075506 Fluoxetine Hydrochloride Solution; Oral SUPPL-24 Teva Labeling Approved Fluoxetine Hydrochloride ANDA #075506 Fluoxetine Hydrochloride Solution; Oral SUPPL-24 Teva Labeling Approved Fluoxetine Hydrochloride ANDA #075514 Fluoxetine Hydrochloride Solution; Oral SUPPL-15 Wockhardt Bio Ag Labeling Approved Fluoxetine Hydrochloride ANDA #075514 Fluoxetine Hydrochloride Solution; Oral SUPPL-15 Wockhardt Bio Ag Labeling Approved Fluoxetine Hydrochloride ANDA #075920 Fluoxetine Hydrochloride Solution; Oral SUPPL-17 Specgx Llc Labeling Approved Fluoxetine Hydrochloride ANDA #075920 Fluoxetine Hydrochloride Solution; Oral SUPPL-17 Specgx Llc Labeling Approved Invega Trinza NDA #207946 Paliperidone Palmitate Suspension, Extended Release; Intramuscular SUPPL-10 Janssen Pharms Efficacy Approved Linagliptin and Metformin Hydrochloride ANDA #208336 Linagliptin; Metformin Hydrochloride Tablet; Oral ORIG-1 Sunshine   Approved Pantoprazole Sodium ANDA #209524 Pantoprazole Sodium Injectable; Iv (Infusion) ORIG-1 Acic Pharms   Approved Oseltamivir Phosphate ANDA #212858 Oseltamivir Phosphate For Suspension; Oral ORIG-1 Aptapharma Inc   Approved Trientine Hydrochloride ANDA #212929 Trientine Hydrochloride Capsule; Oral ORIG-1 Accord Hlthcare   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