Search Results for keywords:"generic drug approval"

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Search Results: keywords:"generic drug approval"

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  • 2025-06783 — Determination That MOBIC (Meloxicam) Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 16691
    Reading Time:about 3 minutes

    The Food and Drug Administration (FDA) determined that MOBIC (meloxicam) tablets, available in 7.5 mg and 15 mg doses, were not withdrawn from sale because of safety or effectiveness concerns. This means that the FDA will continue to approve generic versions of this medicine as long as they meet all legal and regulatory requirements. MOBIC is used to treat arthritis symptoms and is now listed in the "Discontinued Drug Product List," but this listing does not imply any safety issues. The FDA will ensure that any needed updates to the drug's labeling are made.

    Simple Explanation

    MOBIC is a medicine that helps with arthritis and the people in charge, called the FDA, checked and said it wasn't stopped for being bad or not working. This means other companies can still make similar pills if they follow the rules.

  • 2025-06050 — Determination That FLUMADINE (Rimantadine Hydrochloride) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 15243
    Reading Time:about 4 minutes

    The Food and Drug Administration (FDA) has determined that the drug FLUMADINE (rimantadine hydrochloride) 100 mg tablets were not taken off the market due to safety or effectiveness concerns. As a result, the FDA will not start withdrawing approval for generic versions of this drug, and it may continue approving them if they meet legal standards. FLUMADINE was originally approved in 1993 for treating and preventing influenza A in adults and for prevention in children. Despite being discontinued by the manufacturer, it remains listed in the Orange Book as discontinued for reasons other than safety or effectiveness.

    Simple Explanation

    The FDA says that the medicine FLUMADINE, which helps stop the flu, wasn't sold anymore, but not because it's unsafe or doesn't work. They will still let other companies make a similar medicine if they follow the rules.