Go to Wolters Kluwer VitalLaw.comGo to Wolters Kluwer VitalLaw.com
VitalLaw®
  • Find answers to your questions
  • Log in to access your subscriptions
In depth. On point.
In depth. On point.
  • Home
  • Legal Directory
  • Home
  • Legal Directory
In depth. On point.
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations
    • PRESCRIPTION DRUGS—D.D.C.: IRA’s Drug Price Negotiation Program not unconstitutional, federal trial court holds
    • BILLING AND CODING—SETTLEMENT AGREEMENTS: In-home health provider will pay $2.4 million to settle Medicare Advantage false coding claim
    • CONDITIONS OF PARTICIPATION—DAB DECISIONS: Patient abuse and neglect conviction basis for 5-year exclusion, despite being ‘excessively harsh’ according to ALJ
    • CONTROLLED SUBSTANCES—FINAL RULES: DEA targets emerging kratom-derived opioids with Schedule I action
    • CONTROLLED SUBSTANCES—NOTICES: FDA seeks input on global drug controls
    • DRUGS AND BIOLOGICS—NOTICES: FDA clears path for generic Cabazitaxel
    • FALSE CLAIMS ACT—D. Mass.: Court grants in part motions to quash subpoenas of non-parties in qui tam action
    • GENERIC DRUGS—D.C. Cir.: Norwich wins partial appeal over rifaximin exclusivity dispute; court orders FDA reconsideration
    • HATCH WAXMAN ACT—D. Del.: Court rejects Vertex bid to expand ivacaftor patent scope
    • MEDICAID—GAO REPORTS: Millions of working adults, many employed by the nation’s largest companies, remain enrolled in Medicaid and SNAP
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations

    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: FDA clears path for generic Cabazitaxel, (Aug 28, 2026)

    By WK Editorial Staff

    FDA said the discontinued prostate cancer drug remains eligible as a reference product for future generic applications.

    The FDA determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), was not withdrawn from sale for reas ...

    By WK Editorial Staff

    FDA said the discontinued prostate cancer drug remains eligible as a reference product for future generic applications.

    The FDA determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness, allowing the agency to continue approving abbreviated new drug applications (ANDAs) that reference the product if all other regulatory requirements are met. The drug, approved in 2024 for use with prednisone to treat certain patients with metastatic castration-resistant prostate cancer, was discontinued by its manufacturer and moved to the Orange Book's Discontinued Drug Product List. After reviewing a citizen petition, agency records, relevant literature, and postmarketing safety data, FDA found no evidence that the product was withdrawn because of safety or effectiveness concerns. The agency will keep the product listed as discontinued for commercial reasons and may require any future generic applicants to update labeling to meet current standards (Notice, 91 Fed. Reg. 55102 (Aug. 26, 2026)).

    Dates. August 25, 2026.

    FederalRegisterIssuances: FinalRules FDCActNews DrugBiologicNews GenericDrugNews SafetyNews

    © 2026 CCH Incorporated and its affiliates and licensors. All rights reserved.

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use