Drug Development

Somaxon Pharmaceuticals Provides Update on SILENOR Development Program

Published in FDA Law Weekly, May 24th, 2007

Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) today provided an update on its non-clinical program for SILENOR(TM) (doxepin HCl), its lead product candidate that has completed a successful Phase 3 clinical program for the treatment of insomnia.

On May 8, 2007, Somaxon received correspondence from the U.S. Food and Drug Administration (FDA) in which the FDA stated that the results of the company's ongoing 26-week transgenic mouse carcinogenicity study of SILENOR(TM) should be included as part of the initial New Drug Application (NDA) submission for SILENOR(TM). This request may result in the company delaying its initial NDA submission until the first quarter of...

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Source: FDA Law Weekly (2007-05-24)

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