FDA Revokes Approval for Mysoline (Primidone) Suspension

AI-generated NewsSnap summary based on source reporting.
Published: 2026-09-29
Category: health
Source: Federal Register
Original source

The U.S. FDA has withdrawn approval for FHTA LLC's Mysoline (Primidone) Suspension, 250 mg/5 mL. This regulatory action impacts the availability and safety profile of the medication, signaling a significant development for patients and healthcare providers who rely on this specific formulation.

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