What's New Related to Drugs

What's New Related to Drugs Updated Monday through Friday - Current and Resolved Drug Shortages and Discontinuations Reported to FDA - 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 - Drugs@FDA Data Files Updated Biweekly March 31, 2026 - FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis - New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS) (Updated) March 30, 2026 - Public Notifications: March 27, 2026 March 25, 2026 March 20, 2026 - FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma - Drug Safety Communication: FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products Containing Carbidopa/Levodopa March 17, 2026 - Final Guidance: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs March 13, 2026 - Public Notification: Kian Pee Wan may be harmful due to hidden drug ingredients - Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations - Orange Book Current Cumulative Supplement (updated) - Additions/Deletions for Prescription and OTC Drug Product Lists (updated) - Orange Book Data Files (compressed) (updated) - Reference Listed Drugs by ANDA Reference Standard List (updated) - Orange Book Patent Listing Dispute List (updated) March 9, 2026 - Final Guidance: Questions and Answers on Biosimilar Development and the BPCI Act - Draft Guidance: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) March 6, 2026 March 5, 2026 March 4, 2026 - Event: Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop - FDA approves drug for pediatric patients with most common form of dwarfism March 3, 2026 - Public Notification: Artri Ajo Rev and Artri Ajo King may be harmful due to hidden drug ingredients (Updated) - Final Guidance: M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines - Final Guidance: E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports - Draft Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers February 27, 2026