US FDA accepts Somaxon's complete response for Silenor
This article was originally published in Scrip
Executive Summary
The US FDA has accepted Somaxon's resubmission of the NDA for its troubled insomnia drug Silenor (doxepin) following the complete response letter it issued in June. The company's share price soared by 82%, closing at $2.40 on Nasdaq on January 22nd.