Search Results for keywords:"oral solution"

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Search Results: keywords:"oral solution"

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  • 2025-04020 — Determination That RIOMET (Metformin Hydrochloride) Oral Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 11991
    Reading Time:about 3 minutes

    The Food and Drug Administration (FDA) confirmed that RIOMET, a metformin hydrochloride oral solution, was not taken off the market for safety or effectiveness issues. This finding means that the FDA can continue approving generic versions of this medication if they meet legal requirements. RIOMET is listed as discontinued in the FDA's "Orange Book," but this is not due to any safety concerns. As a result, companies can still seek approval to produce generic versions of RIOMET, provided they comply with all necessary regulations.

    Simple Explanation

    The FDA says that a type of liquid medicine called RIOMET, which helps control blood sugar, was not taken off shelves because it was dangerous or didn't work. This means that other companies can make and sell this medicine too, as long as they follow the rules.

  • 2021-03083 — Determination That NYMALIZE (nimodipine), Oral Solution, 3 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    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.