FDA withdraws approval of long-discontinued MYSOLINE suspension
Oct 11, 2026 edition · GC-2026-0164 · Published 2026-10-11 · Version 3 · Withdrawn
FDA withdrew approval of the specific MYSOLINE primidone suspension NDA effective September 29. The product had been discontinued in 2001, and its holder agreed to withdrawal and waived a hearing. The notice concerns that formulation and application, rather than withdrawing all primidone products.
What happened
FDA's September 29 notice withdraws approval of NDA 010401 for MYSOLINE primidone suspension, 250 mg per 5 mL, held by FHTA LLC. Approval and all amendments and supplements are withdrawn as of that date after the holder agreed and waived its opportunity for a hearing. The action follows FDA's earlier determination that this suspension had been withdrawn from sale for safety or effectiveness reasons; it is not a newly announced class-wide withdrawal of primidone.
The notice traces the suspension's discontinuation to 2001, when antimicrobial-effectiveness testing raised microbial-contamination concerns, particularly Pseudomonas aeruginosa. FDA had explained that reintroduction would require reformulation, appropriate preservative acceptance criteria, passing testing, and evidence of safety and effectiveness, and that no new formulation had then been approved. In June 2026, the holder chose withdrawal rather than a hearing. The resulting notice makes interstate distribution of the specified suspension without an approved application unlawful; the product name, concentration, and NDA identify the action's scope.
Scope and timing
- Authority status
- Withdrawn
- Applicability
- Operationally relevant
- Audience
- Health systems, Provider networks
- Jurisdiction
- Federal
Why it matters
Formulary and medication data should distinguish the affected suspension from other formulations. Treating this as a class-wide withdrawal would be inaccurate.
Recommended action
Check formulary and product master data for the specific discontinued NDA and verify any remaining reference to that suspension.
Sources
- FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 MillilitersOfficial · Health and Human Services Department, Food and Drug Administration · 2026-09-29 · Source review 2026-10-11
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