FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT MYSOLINE (PRIMIDONE) SUSPENSION, 250 MILLIGRAMS/5 MILLILITERS, WAS WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Jan. 2 -- Food and Drug Administration has issued a notice called: Determination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Jan. 2 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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(FDA, Agency, or we) has determined that MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), was withdrawn from sale for reasons of safety or effectiveness.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.

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