CDER New: 9/30/2021

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 September 29, 2021 Manual of Policies and Procedures (MAPP) 4100.2 CDER Staff Participation in Public Private Partnerships and Consortia Competitive Generic Therapy Approvals FDA Drug Shortages Continuous Renal Replacement Therapy (CRRT) Solutions (Updated - Currently in Shortage) Dobutamine Hydrochloride Injection (Updated - Currently in Shortage) Dopamine Hydrochloride Injection (Updated - Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Mannitol Injection (New - Currently in Shortage) Guidance for Industry Q3B(R) Impurities in New Drug Products (Revision 3) Benefit-Risk Assessment for New Drug and Biological Products Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices Microbiological Quality Considerations in Non-Sterile Drug Manufacturing 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. September 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Livmarli NDA #214662 Maralixibat Solution; Oral ORIG-1 Mirum Pharma Inc Type 1 - New Molecular Entity Approved September 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Clobazam ANDA #209308 Clobazam Tablet; Oral SUPPL-6 Breckenridge Labeling Approved Clobazam ANDA #209308 Clobazam Tablet; Oral SUPPL-6 Breckenridge Labeling Approved Mavyret NDA #209394 Glecaprevir; Pibrentasvir Tablet; Oral SUPPL-14 Abbvie Inc Labeling Approved Mavyret NDA #209394 Glecaprevir; Pibrentasvir Tablet; Oral SUPPL-14 Abbvie Inc Labeling Approved Prochlorperazine Edisylate ANDA #213626 Prochlorperazine Edisylate Injectable; Injection ORIG-1 Viwit Pharm   Approved Mavyret NDA #215110 Glecaprevir; Pibrentasvir Pellets; Oral SUPPL-1 Abbvie Inc Labeling Approved Mavyret NDA #215110 Glecaprevir; Pibrentasvir Pellets; Oral SUPPL-1 Abbvie Inc Labeling Approved Qulipta NDA #215206 Atogepant Tablet; Oral ORIG-1 Abbvie Inc Type 1 - New Molecular Entity 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