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

June 10, 2026

• Public Notifications:
  • Business Pill may be harmful due to hidden drug ingredient
  • Branch Manager for Men may be harmful due to hidden drug ingredient
• Webinar: ClinicalTrials.gov: Essentials for Academic Medical Centers
• Drug Safety Communication: FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

June 5, 2026

• Public Notification: Pink Pussycat Brand products may be harmful due to hidden drug ingredients

June 4, 2026

• Public Notifications:
  • Juicy AF! may be harmful due to hidden drug ingredient
  • Lipofit Extreme 2.0 Fat Burner may be harmful due to hidden drug ingredients
• Final Guidance: Certain Postapproval Requirements and Resources for ANDAs

June 3, 2026

• CDER Statement: FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury

June 2, 2026

• Draft Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
• Final Guidance: M15 General Principles for Model-Informed Drug Development

May 29, 2026

• Public Notifications: 
  • Tawon Liar contains hidden drug ingredient (updated)
  • Sensual Miracle Honey may be harmful due to hidden drug ingredients
  • Baipho Herbs Tea Drink may be harmful due to hidden drug ingredient
  • Erectus Plus may be harmful due to hidden drug ingredients
  • X10 Natural Enhancement Supplement may be harmful due to hidden drug ingredients
  • Big Dick Energy! may be harmful due to hidden drug ingredient
• Final Guidance: Q8, Q9, and Q10 Questions and Answers (R5) (updated)

May 28, 2026

• FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
• Final Guidance: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
• Final Guidance: Statistical Approaches to Establishing Bioequivalence

May 27, 2026

• Public Notification: biQ-FEL may be harmful due to hidden drug ingredients
• FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy

May 22, 2026

• FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer

May 20, 2026

• Webinar: Eco-NAMs Webinar Series | In Silico Approaches to Replace Acute Fish Toxicity

May 15, 2026

• Alert: FDA warns consumers not to use expired Amazon Basic Care Levonorgestrel 1.5 mg
• FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
• FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis
• Public Notification: Sâm Xương Khớp Ông Tiên may be harmful due to hidden drug ingredients
• FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease

May 13, 2026

• FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
• FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
• Draft Guidance: Development of Non-Opioid Analgesics for Acute Pain (Updated)
• Draft Guidance: Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework (Updated)
• Draft Guidance: Development of Local Anesthetic Drug Products With Prolonged Duration of Effect (Updated)
• Draft Guidance: Stimulant Use Disorders: Developing Drugs for Treatment (Updated)
• Draft Guidance: Development of Non-Opioid Analgesics for Chronic Pain (Updated)
• Drug Trials Snapshots: Forzinity

May 11, 2026

• FDA News Release: FDA Advances Drug Repurposing to Address Unmet Medical Needs
• CDER Statement: FDA Alerts Health Care Providers and Patients about Increased Risk of New Blood Cancers with Tazverik (tazemetostat) Use; Sponsor to Voluntarily Withdraw Product from Market
• Workshop: Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations