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Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product
Date:6/30/2008

- Company Expects to Submit Complete Response by End of Week -

LAVAL, QC, June 30 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that the Company has received a response from the U.S. Food and Drug Administration (FDA) regarding its most recent appeal of the decision in the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process.

Procedurally, Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research, agreed with Dr. Jenkins, M.D., Director for the Office of New Drugs, Center for Drug Evaluation and Research and denied the appeal. However, he suggested a regulatory path forward. Dr. Throckmorton has suggested that the Company submit the analysis put forward by Dr. Jenkins in his letter of earlier this year. In the response, the FDA has concluded that a positive finding using this analysis could provide the needed assurance to support the efficacy of Labopharm's once-daily tramadol. Following resolution of any issues with labeling, such a finding would lead to the approval of the product.

The Company expects to submit the complete response before the end of the week and the FDA has agreed to conduct its review of the response in a timely basis.

"We are encouraged by the Agency's request to formally submit the data analysis that Dr. Jenkins suggested we undertake and believe that this is a positive step towards regulatory approval in the U.S.," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "The request follows a meeting with the FDA, as well as constructive discussions over the past two months. We continue to believe that the comprehensive data generated by our global clinical trial program demonstrates the efficacy and safety of our once-daily tramadol formulation and that we have met the statutory standards for approval of our formulation."

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SOURCE Labopharm Inc.
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