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 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- Draft Guidance: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)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- Draft Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers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
February 26, 2026
- Public Notification: ULTRA ADVANC3 and ULTRA ADVANC3 GOLD may be harmful due to hidden drug ingredients
- FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
February 24, 2026