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    • FALSE CLAIMS ACT—D. Mass.: Government granted leave to file second motion for partial summary judgment in FCA/AKS lawsuit
    • ADMINISTRATION OF FDC ACT—NOTICES: Roxicet tablet was not withdrawn from sale for reasons of safety, effectiveness
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    Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Roxicet tablet was not withdrawn from sale for reasons of safety, effectiveness, (Aug 6, 2025)

    By WK Editorial Staff

    Roxicet is indicated for the relief of moderate to moderately severe pain.

    The FDA has determined that roxicet (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 mg, was not withdrawn from sale for reasons of safety or eff ...

    By WK Editorial Staff

    Roxicet is indicated for the relief of moderate to moderately severe pain.

    The FDA has determined that roxicet (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 mg, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the FDA to approve abbreviated new drug applications (ANDAs) for oxycodone HCl and acetaminophen tablet, 5 mg/325 mg, if all other legal and regulatory requirements are met. Roxicet (oxycodone HCl and acetaminophen) tablet, 5 mg/325 mg, is the subject of ANDA 087003, held by Hikma Pharmaceuticals USA Inc., and initially approved on February 25, 1980 (Notice, 90 Fed. Reg. 36441, August 4, 2025).

    Dates. July 29, 2025.

    FederalRegisterIssuances: Notices FDCActNews DrugBiologicNews SafetyNews

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