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

February 13, 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)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Public Notifications:
  • LOVION Chocolate with Ginseng for Men may be harmful due to hidden drug ingredients
  • Fantasy Aphrodisiac Chocolate may be harmful due to hidden drug ingredient
  • DTF Sexual Chocolate may be harmful due to hidden drug ingredients
  • Boner Bears Chocolate may be harmful due to hidden drug ingredient

February 11, 2026

• Public Notifications:
  • Pink Pussycat Aphrodisiac Chocolate may be harmful due to hidden drug ingredient
  • Rhino Choco VIP Chocolate for Men may be harmful due to hidden drug ingredient
  • ilum Male Sexual Enhancement Chocolate may be harmful due to hidden drug ingredient
• Draft Guidance: Certification Process for Designated Medical Gases

February 10, 2026

• FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

February 5, 2026

• Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
• Draft Guidance: E22 General Considerations for Patient Preference Studies

February 4, 2026

• Drug Trials Snapshots: LEROCHOL
• Drug Trials Snapshots: WAYRILZ

February 2, 2026

• Umary contains hidden drug ingredients
• Drug Trials Snapshots: REDEMPLO

January 27, 2026

• FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

January 21, 2026

• Drug Trials Snapshots KYGEVVI
• FDA Announces PreCheck Implementation Roadmap

January 20, 2026

• Draft Guidance: M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

January 13, 2026

• FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications

January 12, 2026

• Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products