Somaxon Revises FDA Application

Denise Gellene1/21/10

San Diego-based Somaxon said it submitted a revised application for its experimental sleeping pill doxepin (Silenor) to the FDA today, with a decision expected by March 21. The revised application addressed the agency’s questions about the efficacy of the drug in non-elderly adults, according to a Somaxon press release. The FDA has rejected Somaxon’s application to market doxepin twice.

Denise Gellene is a former Los Angeles Times science writer and regular contributor to Xconomy. You can reach her at dgellene@xconomy.com