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Article: Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol.
- Article from:
- PR Newswire
- Article date:
- November 21, 2007
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LAVAL, QC, Nov. 21 /PRNewswire-FirstCall/ -- Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its appeal of the Agency's Approvable Letter for its once-daily tramadol formulation through the Formal Dispute Resolution process. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research has not overturned the decision in the Agency's Approvable Letter of May 2007.
Labopharm plans to appeal the matter to the next supervisory level at the FDA in the coming weeks.
Labopharm initiated the Formal ...