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    • DRUGS AND BIOLOGICS—NOTICES: FDA determines VIBRAMYCIN was not withdrawn from sale for reasons of safety or effectiveness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    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: FDA determines VIBRAMYCIN was not withdrawn from sale for reasons of safety or effectiveness, (Apr 14, 2025)

    By WK Editorial Staff

    Accordingly, the Agency will continue to list VIBRAMYCIN (doxycycline) for oral suspension, EQ 25mg base/5 mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book.

    The Food and Drug Administration (FDA, Age ...

    By WK Editorial Staff

    Accordingly, the Agency will continue to list VIBRAMYCIN (doxycycline) for oral suspension, EQ 25mg base/5 mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book.

    The Food and Drug Administration (FDA, Agency) has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements (Notice, 90 Fed. Reg. 15253 (Apr. 9, 2025)).

    Dates. April 8, 2025.

    FederalRegisterIssuances: Notices AdvertisingNews DrugBiologicNews SafetyNews

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

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use