Notice2025-24196
Determination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 2, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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(FDA, Agency, or we) has determined that MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), was withdrawn from sale for reasons of safety or effectiveness.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.
Indexed from Federal Register on January 2, 2026.
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