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Pfizer pregabalin NDA

Executive Summary

Pfizer will submit pregabalin NDA in the U.S. following March 2003 European submission, company says Sept. 6. Filing will include FDA-requested toxicological mechanistic studies. Pfizer had hoped to submit the application in 2002. The delay is the second for the Neurontin follow-on; the NDA was delayed in late 2001 while Pfizer added carcinogenicity data and studies supporting a generalized anxiety disorder indication (1"The Pink Sheet" Dec. 24, 2001, p. 18). Pfizer is seeking approval for add-on epilepsy, neuropathic pain and GAD...
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