Executive Summary

Letter to the May 5 Journal of the American Medical Association from FDA's Stuart Nightingale, Peter Rheinstein and James Morrison says agency concludes "no bioequivalence problem with the generic product could be confirmed." The FDA letter responds to Sept. 4, 1987 article entitled "Increased Seizure Frequency with Generic Primidone," which detailed poor response of one patient who had been switched from Wyeth-Ayerst's Mysoline to the generic. An accompanying letter from Bolar points out that Cleveland Clinic incident "clearly indicated that there was no evidence of generic failure since this patient responded poorly" to both versions of the drug," and notes that Bolar sales of product were negatively impacted by article.