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Generic phenytoin

Executive Summary

FDA's Generic Drugs Advisory Committee will discuss "issues on bioequivalence related to narrow therapeutic range drugs such as phenytoin" during its Feb. 10-12 meeting. FDA's request for advice from the committee on the anticonvulsant is precipitated in part by Warner-Lambert's recent manufacturing difficulties with its Dilantin Kapseal product and the lack of a generic slow-release or controlled-release version. FDA met with the company on Jan. 11 to discuss reformulation of the brandname product. The advisory committee meeting begins 8 a.m. at the Holiday Inn in Silver Spring, Md.
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PS022058

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