FDA Revokes Approval for MYSOLINE Suspension Over Safety and Efficacy Issues

The FDA has formally withdrawn approval for MYSOLINE (primidone) suspension, a decision supported by FHTA LLC. This action stems from the product's discontinuation in 2001 due to microbial contamination concerns, specifically Pseudomonas aeruginosa, and a January 2026 determination of withdrawal for safety or effectiveness reasons. Reintroduction would necessitate reformulation and new safety/effectiveness demonstrations.