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

Updated Weekly

• Drugs@FDA Data Files 

Updated Biweekly

• Competitive Generic Therapy Approvals

February 14, 2025

• FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor
• 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)
• CDER Statement: FDA qualifies drug development tool to facilitate clinical trial research on alcohol use disorder

February 11, 2025

• FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection

February 10, 2025

• FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection
• Public Notifications:
  • HimGo may be harmful due to hidden drug ingredients
  • ADVANCE KING may be harmful due to hidden drug ingredients
  • vROX may be harmful due to hidden drug ingredient
  • bio LIT may be harmful due to hidden drug ingredient
  • Special Edition Platinum 10K contains hidden drug ingredients
  • VITALITY may be harmful due to hidden drug ingredients

January 30, 2025

• Drug Safety Communication (Spanish): La FDA agrega un recuadro de advertencia sobre una reacción alérgica poco frecuente pero grave, llamada anafilaxia, al acetato de glatiramero (Copaxone, Glatopa), un medicamento para la esclerosis múltiple

January 29, 2025

• Drug Safety Communication (Chinese): FDA 針對多發性硬化症藥物 glatiramer acetate（商品名：可舒鬆 (Copaxone)、Glatopa）新增黑框警告，提醒注意罕見但嚴重的過敏反應（全身性過敏反應）風險

January 17, 2025

• FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer

January 16, 2025

• CDER Alert: FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA
• Webinar: Navigating Controlled Correspondences to Support Generic Drug Development
• Webinar: Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

January 14, 2025

• Drug Trials Snapshots: ZIIHERA

January 13, 2025

• Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals: Development and Application of the Carcinogenic Potency Categorization Approach

January 10, 2025

• Drug Trials Snapshots: EXXUA