Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) 65.6% LOWER; today announced that the company has received a Complete Response Letter from the U.S.
FDA for its New Drug Application for Silenor(R) (doxepin) for the treatment of insomnia. Based on its review, the FDA has determined that the NDA cannot be approved in its present form.
Somaxon previously received a Complete Response Letter for the NDA in February 2009, and it resubmitted the NDA in June 2009.
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