Labopharm Submits Its Response To FDA

Labopharm has submitted its response to the FDA’s complete response letter regarding the company’s novel formulation of the antidepressant – trazodone.

As previously announced, Labopharm received a complete response letter from the FDA on July 17, 2009. The letter indicated that the company’s new drug application for its novel trazodone formulation could not be approved in its present form, due to deficiencies following FDA’s inspection of the active pharmaceutical ingredient (API) manufacturing facility. The letter did not raise any efficacy or safety issues, said the company.

FDA is expected to notify Labopharm within 14 days as to whether or not the company’s response has been accepted for review. Once accepted, and in accordance with the Prescription Drug User Fee Act (PDUFA), the FDA will assign Labopharm a new action date.