Search Results for keywords:"rimantadine hydrochloride"

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Search Results: keywords:"rimantadine hydrochloride"

  • 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.