CDER New: 5/12/2021

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 May 12, 2021 2020 Office of Surveillance and Epidemiology Annual Report (new) May 11, 2021 Drugs@FDA Data Files (updated) FDA Drug Shortages Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage) Identification of Medicinal Products: Path to Global Implementation Guidance for Industry: M9 Biopharmaceutics Classification System-Based Biowaivers E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials Q3D(R2) – Guideline for Elemental Impurities S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals Qualified Infectious Disease Product Designation Questions and Answers Novo Nordisk Issues Voluntary Nationwide Recall of Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Samples Due to Improper Storage Temperature Conditions 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. May 11, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Avapro NDA #020757 Irbesartan Tablet; Oral SUPPL-75 Sanofi Aventis Us Labeling Approved Avalide NDA #020758 Hydrochlorothiazide; Irbesartan Tablet; Oral SUPPL-81 Sanofi Aventis Us Labeling Approved Aimovig BLA #761077 Erenumab-Aooe Injectable; Injection SUPPL-11 Amgen Inc Labeling Approved May 10, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Indomethacin ANDA #200529 Indomethacin Capsule, Extended Release; Oral SUPPL-3 Chartwell Rx Labeling Approved Indomethacin ANDA #200529 Indomethacin Capsule, Extended Release; Oral SUPPL-3 Chartwell Rx Labeling Approved Leflunomide ANDA #213497 Leflunomide Tablet; Oral ORIG-1 Axunio   Approved Erlotinib Hydrochloride ANDA #214366 Erlotinib Hydrochloride Tablet; Oral ORIG-1 Msn   Approved Chlordiazepoxide Hydrochloride and Clidinium Bromide ANDA #214698 Chlordiazepoxide Hydrochloride; Clidinium Bromide Capsule; Oral ORIG-1 Dr Reddys   Approved Gabapentin ANDA #214956 Gabapentin Capsule; Oral ORIG-1 Ascent Pharms Inc   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