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FDA accepts Labopharm's response for once-daily tramadol as complete Class 2 response
Date:7/17/2008

- FDA Assigns PDUFA Date of January 2, 2009 -

LAVAL, QC, July 17 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that the response that it submitted to the U.S. Food and Drug Administration (FDA) on July 2, 2008, including the additional analysis of existing data as suggested by the Agency, has been accepted as a complete, Class 2 response. The action date assigned by the FDA under the Prescription Drug User Fee Act (PDUFA) is January 2, 2009.

About Labopharm's Once-Daily Tramadol Product

Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid(R) technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been launched in 12 countries, including the five largest markets in Europe and Canada and is approved in 18 other countries. Including those countries in which its product has been launched, Labopharm has licensing and distribution agreements in place for more than 50 markets globally.

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 being commercially launched in key markets globally. 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
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SOURCE Labopharm Inc.
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