FDA accepts Silenor NDA

FDA accepted for review the resubmission of an NDA from Somaxon Pharmaceuticals Inc. (NASDAQ:SOMX) for Silenor doxepin to treat insomnia. The PDUFA date is Dec. 4. The compound is a low-dose formulation of doxepin, a serotonin and noradrenaline reuptake inhibitor. The application was submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act. ...