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Article: Somaxon Pharmaceuticals Submits New Drug Application for SILENOR(TM) for the Treatment of Insomnia.
- Article from:
- Business Wire
- Article date:
- January 31, 2008
CopyrightCOPYRIGHT 2008 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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SAN DIEGO -- Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), 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 has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR[TM] (doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR[TM] for the treatment of insomnia.
Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the company ...