Search Results for keywords:"3 mg/mL"

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Search Results: keywords:"3 mg/mL"

  • Type:Notice
    Citation:86 FR 9944
    Reading Time:about 5 minutes

    The Food and Drug Administration (FDA) has decided that the drug NYMALIZE (nimodipine), oral solution at a strength of 3 mg/mL, was not taken off the market for safety or effectiveness reasons. This decision enables the approval of generic versions of this drug, provided they meet other requirements. Although the 3 mg/mL version was discontinued, the FDA believes it would still be safe and effective if sold today, but suggests making some labeling changes to prevent confusion with another version that is 6 mg/mL.

    Simple Explanation

    The FDA says a medicine called NYMALIZE, which helps people, was stopped being sold, but not because it was dangerous or didn't work. This means other companies can make the same medicine, but they should use the right labels so nobody mixes it up with a stronger one.