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Warner-Lambert’s Cognex (tacrine)

Executive Summary

FDA issues "approvable" letter for the Alzheimer's drug May 10. Cognex was recommended for approval after a third advisory committee review March 18. Warner-Lambert has said that it expects Cognex labeling to require a less demanding schedule of blood monitoring in patients for elevated transaminase levels than the weekly monitoring used in the clinical trials. That issue, however, apparently has not been resolved.
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PS022645

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