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 the U.S. Food and Drug Administration (FDA) has notified the company that it has accepted for filing the company's New Drug Application (NDA) for SILENOR™(doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR™for the treatment of insomnia.
Acceptance of the filing means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the NDA is considered filed as of March 31, 2008, and Somaxon expects that the FDA will complete its review and provide an action letter with respect to the NDA by December 1, 2008.
“We are pleased that the FDA has accepted our application for filing and we look forward to working with them as we seek approval for SILENOR™for the treatment of insomnia,”said David F. Hale, Somaxon’s executive chairman and interim chief executive officer. “While acceptance for filing of an NDA does not assure approval, we believe that the improvements in sleep onset, sleep maintenance and sleep duration and the favorable safety and tolerability profile demonstrated by our clinical development program will be sufficient to support a determination by the FDA that SILENOR can be approved for the treatment of insomnia.”
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