Labopharm Receives FDA’s Complete Response Letter For Antidepressant

Labopharm has received a complete response letter from FDA for the new drug application (NDA) submission of its novel formulation of the antidepressant – trazodone.

The letter indicates that 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. The FDA letter states: Satisfactory resolution of these deficiencies is required before this application may be approved.

The API manufacturer, Angelini, has informed Labopharm that it 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 US market.

James Howard-Tripp, president and CEO of Labopharm, said: We intend to work closely with the FDA and Angelini to resolve these issues as rapidly as possible. We continue to prepare for the commercialization of our novel antidepressant and intend to launch in the US market as soon as possible after we receive approval.