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Somaxon Submits NDA for Insomnia Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Somaxon Pharmaceuticals, Inc. has submitted a NDA to the FDA for Silenor for the treatment of insomnia.The FDA is expected to make a decision within 60 days. If the NDA is accepted, the FDA will complete its review and provide an action letter within 10 months following submission of the NDA, or in December 2008.     “The completion and submission of our NDA for Silenor represents a significant milestone for Somaxon,” said David F. Hale, Somaxon’s executive chairman and interim ch...

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