Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has submitted its response to the U.S. Food and Drug Administration's (FDA) 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 indicating the Company's new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to deficiencies following the FDA's inspection of the active pharmaceutical ingredient (API) manufacturing facility. The letter did not raise any efficacy or safety issues.
The 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.
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