What's New Related to Drugs

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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

• Competitive Generic Therapy Approvals

April 17, 2026

• Draft Guidance: Establishing Impurity Specifications for Antibiotics

April 16, 2026

• CDER Statement: First FDA-Approved Treatment for Patients with Focal Segmental Glomerulosclerosis—A Rare Kidney Condition
• FDA Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies
• Public Meeting: Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments

April 10, 2026

• 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)
    • Appendix A: Product Name Index (updated)
    • Appendix B: Product Name Sorted by Applicant (updated)
    • Appendix C: Uniform Terms (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Workshop: FDA/Center for Research on Complex Generics (CRCG) Workshop on Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products

April 7, 2026

• CDER Statement: FDA Approves First Generic Dapagliflozin Tablets
• Public Notifications: 
  • WAP Sensual Enhancement may be harmful due to hidden drug ingredients
  • Curcuflex may be harmful due to hidden drug ingredients
  • RM Joe may be harmful due to hidden drug ingredients
  • DINA Acido Hialurónico may be harmful due to hidden drug ingredients
  • KUKA FLEX CBD may be harmful due to hidden drug ingredient
  • Yeicob Ácido Hialurónico may be harmful due to hidden drug ingredients
• Public Workshop: Optimizing Pregnancy Registries

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:
  • Red Bull Extreme and Blue Bull Extreme may be harmful due to hidden drug ingredient
  • Boner Bears Honey may be harmful due to hidden drug ingredients

March 27, 2026

• Drug Trials Snapshots: CARDAMYST

March 25, 2026

• FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

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