25-year-old drug suspension yanked by FDA at last.
Published Date: 9/29/2026
Notice
Summary
The FDA is officially pulling the approval for MYSOLINE (primidone) suspension, a medicine that hasn’t been sold since 2001 due to safety concerns. FHTA LLC, the company behind it, agreed to this withdrawal without a fight. This means MYSOLINE suspension won’t be coming back unless it’s reformulated and proven safe and effective, so patients and pharmacies should look for other options starting September 29, 2026.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
Reformulation and testing required to return
FDA stated that, before MYSOLINE (primidone) suspension, 250 mg/5 mL, could be reintroduced, a reformulation would be required including establishment of preservative content acceptance criteria and correlation with passing antimicrobial effectiveness testing results, and the NDA holder would have to demonstrate the safety and effectiveness of the reformulated product.
Approval withdrawn for MYSOLINE suspension
The FDA withdrew approval of NDA 010401 for MYSOLINE (primidone) suspension, 250 mg/5 mL, effective September 29, 2026. FDA previously found the product was discontinued from sale in 2001 for reasons of safety or effectiveness tied to potential microbial contamination (including Pseudomonas aeruginosa); the product was originally approved on July 5, 1956.
Interstate distribution now illegal without approval
As of September 29, 2026, distribution of MYSOLINE (primidone) suspension, 250 mg/5 mL, into interstate commerce without an approved application is illegal and subject to regulatory action under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
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