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Labopharm submits response to FDA for novel antidepressant
Date:8/11/2009

LAVAL, QC, Aug. 11 /PRNewswire-FirstCall/ - 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.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is now available in 17 countries around the world, including the U.S., Canada, major European markets and Australia. The Company's second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review in the U.S. by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labo
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SOURCE Labopharm Inc.
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