Search Results for keywords:"Teva Pharmaceuticals"

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Search Results: keywords:"Teva Pharmaceuticals"

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  • 2025-00742 — Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
    Type:Notice
    Citation:90 FR 3876
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) has decided to withdraw its approval of 23 abbreviated new drug applications (ANDAs) after being informed by the applicants that these drug products are no longer being marketed. This withdrawal is effective from February 14, 2025. The applicants have waived their right to a hearing regarding this decision. According to the regulations, any remaining inventory of these products can be dispensed until it runs out, expires, or otherwise becomes non-compliant.

    Simple Explanation

    The FDA is stopping the official approval of some medicines because the companies told them no one is selling these medicines anymore. They can still be used until they're gone or too old.

  • 2025-00743 — Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications
    Type:Notice
    Citation:90 FR 3877
    Reading Time:about a minute or two

    The FDA is withdrawing approval for 12 new drug applications (NDAs) because the drugs are no longer being sold, and the companies that own them have requested this action. The approval withdrawal, effective February 14, 2025, affects all parts of the applications, including any dosage forms or strengths. Any remaining stock of these drugs can be sold until it is gone or expires.

    Simple Explanation

    The FDA is taking back its approval for 12 medicines because they aren't being sold anymore, and the companies that own them asked for this. People can still sell or use any leftover stock of these medicines until it's all gone or gets too old.