Monday, November 24, 2008

FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months

Nov 24, 2008 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that it received notification that the U.S. FDA will not be able to complete its review of the company's New Drug Application for Silenor (doxepin) by the Prescription Drug User Fee Act (PDUFA) date of December 1, 2008.

The details can be read here.

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