FDA Withdraws Approval of MYSOLINE (Primidone) Suspension Due to Safety Concerns

The U.S. Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 010401 for MYSOLINE (primidone) suspension, 250 milligrams/5 milliliters, held by FHTA LLC. The withdrawal is effective as of September 29, 2026, following FHTA's agreement and waiver of a hearing. The FDA had previously determined in January 2026 that the product was withdrawn from sale for reasons of safety or effectiveness, citing concerns about potential microbial contamination, particularly with Pseudomonas aeruginosa.