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

August 13, 2026

• Draft Guidance: Container Closure Systems for Human Drugs and Biological Products
•  Sepbember 16, 2026 Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA)

August 12, 2026

• Public Notifications:
  • B. MAGI may be harmful due to hidden ingredients
  • DMagic Plus may be harmful due to hidden ingredients
  • Premium OrgaZEN 10000 may be harmful due to hidden ingredient
  • Anaconda Premium 500K may be harmful due to hidden ingredient

August 10, 2026

• Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)

August 6, 2026

• FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
• September 23 Webinar: Communicating Drug Interaction and QTc Information in the U.S. Prescribing Information

July 31, 2026

• FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
• September 10 Workshop: Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products
• Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
• Final Guidance: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs
• Draft Guidance: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts

July 29, 2026

• Drug Trials Snapshots: DECNUPAZ

July 28, 2026

• FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products

July 24, 2026

• FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
• Notable Approval: FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief

July 23, 2026

• Public Notification: Kangaroo Intense Venus 3000 may be harmful due to hidden drug ingredient
• September 23-24 Workshop: FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway

July 21, 2026

• August 27 Workshop: Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials

July 20, 2026

• August 27 Workshop: Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs

July 17, 2026

• Drug Trials Snapshots: ZYCUBO

July 16. 2026

• FDA Approves First Oral Therapy that Inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) to Lower Bad Cholesterol in Adults with High Cholesterol

July 15, 2026

• September 1 Workshop: FDA/Duke-Margolis Institute for Health Policy Virtual Public Meeting: Innovation in Quantitative Medicine Summit
• September 29 Workshop: FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates

July 14, 2026

• Public Notification: Xian Ling may be harmful due to hidden drug ingredients
• Public Notification: Detoxi Slim contains hidden drug ingredient (Updated)
• FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
• FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

July 13, 2026

• September 14 Public Hearing: Considerations for Potential Future Therapeutic Use of Psychedelic Drugs
•  Notable Approval: FDA Approves First At-home Starting Dose for Alzheimer’s Disease Treatment
• Final Guidance: Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
• Final Guidance: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
• Final Guidance: Psychedelic Drugs: Considerations for Clinical Investigations

July 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)
• FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
• FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications