Labopharm Receives Complete Response Letter From the U.S. FDA for Novel Antidepressant

Labopharm Inc. announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the new drug application (NDA) submission of its novel formulation of the antidepressant trazodone.

The letter indicates Labopharm's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed July 3, 2009. The FDA letter states: "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised.

The API manufacturer, Angelini, has informed Labopharm that, further to the FDA's complete response letter to Labopharm, in which the FDA raises observations concerning the Drug Master File (DMF) holder in the section "Facility Inspections", Angelini can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone hydrochloride to the U.S. market. Angelini intends to address the observations raised by the FDA in an action plan that Angelini is going to submit to the FDA by July 24, 2009.