2025-24196: Determination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA, Agency, or we) has determined that MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for primidone suspension, 250 mg/5 mL.
The agency’s own summary, as published.
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