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May 5, 1989

The Efficacy of Generic Primidone

JAMA. 1989;261(17):2499-2500. doi:10.1001/jama.1989.03420170041014

To the Editor. —  An article entitled "Increased Seizure Frequency With Generic Primidone"1 contained specific observations of a patient, including blood levels, and was of particular concern to the Food and Drug Administration because it alleged the therapeutic failure of a generic primidone product that had been evaluated by the administration as therapeutically equivalent to the trade name product Mysoline.This is to report that the Food and Drug Adminstration's Therapeutic Inequivalence Action Coordinating Committee initiated an investigation on publication of the article. The authors were contacted, investigators looked at hospital records, and samples of the batch of the drug product in question were analyzed. Samples of the product showed that it met all US Pharmacopeia and Food and Drug Administration standards. An inspection of the manufacturer revealed no manufacturing problems. The failure actually occurred in October 1985, nearly 2 years before publication of the article. Three months after switching