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
    • COVID-19—3d Cir.: Hospital’s vaccination mandate was internal policy which did not transform it into a state actor
    • ADMINISTRATION OF FDC ACT—FINAL RULES: Withdrawal of approval of new animal drug application
    • ADMINISTRATON OF FDC ACT—NOTICES: Determination that revia (naltrexone hydrochloride) tablets, 50mg, was not withdrawn from sale for reasons of safety, effectiveness
    • ADVERTISING (FOOD, DRUG & MEDICAL DEVICES)—S.D. Cal : Court dismisses false advertising action involving allegedly mislabelled “healthy” snack bars.
    • DRUGS AND BIOLOGICS—3d Cir.: Biologics manufacturers failed to establish irreparable harm in biosimilar controversy
    • EXPERT INSIGHTS—FDA Turns Up The Heat on GLP 1 Dupes Sold “For Research Use Only,” Finds Intended Use Suggests Otherwise
    • FALSE CLAIMS ACT—D. Mass.: DOJ files complaint alleging Illinois doctor was engaged in a Medicare fraudulent billing scheme
    • FOOD—M.D. Fla.: Florida federal court dismisses baby food contamination suit as shotgun pleading
    • FRAUD AND ABUSE—SETTLEMENT AGREEMENTS: ACA fraud claims resolved in $135M settlement
    • LAW FIRM NEWS—Health and Life Sciences IP Honors and Strategic Growth
    • MEDICAL DEVICES—FINAL RULES: Classification of the transcutaneous electrical nerve stimulator for the relief of congestion
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations

    Health Law Daily Wrap Up, ADMINISTRATON OF FDC ACT—NOTICES: Determination that revia (naltrexone hydrochloride) tablets, 50mg, was not withdrawn from sale for reasons of safety, effectiveness, (Apr 17, 2026)

    By WK Editorial Staff

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product.

    The FDA has determined that revia (naltrexone hydrochloride) ta ...

    By WK Editorial Staff

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product.

    The FDA has determined that revia (naltrexone hydrochloride) tablets, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. The determination means that the 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, 91 Fed. Reg. 20471 (Apr. 16, 2026)).

    Dates. April 16, 2026.

    FederalRegisterIssuances: Notices FDCActNews DrugBiologicNews

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

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use