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
    • FALSE CLAIMS ACT—3d Cir.: Third Circuit affirms dismissal of whistleblower’s False Claims Act suit against drugmakers
    • ANTI-KICKBACK PROHIBITION—OIG ADVISORY OPINIONS: ‘Additional services’ provider can refer own primary care service per HHS advisory opinion
    • ANTITRUST—S.D.N.Y.: Indirect purchasers unable to show Celgene illegally maintained market power
    • DRUGS AND BIOLOGICS—NOTICES: FDA determines VIBRAMYCIN was not withdrawn from sale for reasons of safety or effectiveness
    • DRUGS AND BIOLOGICS—NOTICES: FDA withdraws approval of NDAs
    • EXPERT INSIGHTS—Every Claim You Make, Every Step You Take…CVM Will Be Watching You
    • FRAUD AND ABUSE—5th Cir.: Man accused of healthcare fraud can face a second trial
    • MEDICAID—CMS LETTERS: CMS concerns halt approval of new state proposals and renewals for DSHP, DSIP
    • PRODUCTS LIABILITY (DEVICES)—C.D. Cal.: Cardiac defibrillator manufacture not liable in patient’s death from alleged defects
    • REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments
    • VITAL BRIEFING: Trump signs more Executive Orders as many face court challenges
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations

    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: FDA withdraws approval of NDAs, (Apr 14, 2025)

    By WK Editorial Staff

    The NDAs are being withdrawn after applicants requested the applications be withdrawn and waived their opportunity for a hearing.

    The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple ...

    By WK Editorial Staff

    The NDAs are being withdrawn after applicants requested the applications be withdrawn and waived their opportunity for a hearing.

    The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Therefore, approval of the applications and all amendments and supplements thereto, is hereby withdrawn as of May 9, 2025. Introduction or delivery for introduction into interstate commerce of products without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are in inventory on May 9, 2025 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first (Notice, 90 Fed. Reg. 15247 (Apr. 9, 2025)).

    Dates. Approval is withdrawn as of May 9, 2025.

    FederalRegisterIssuances: Notices AdvertisingNews DrugBiologicNews

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

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use