Item 8.01. Other Events
On November 24, 2008, Somaxon Pharmaceuticals, Inc. announced that it
received notification that the U.S. Food and Drug Administration (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 FDA indicated that the review would be extended for up to
three additional months, resulting in a new PDUFA date of February 28, 2009.
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