FDA Responds to Labopharm’s Appeal of Tramadol Approvable Letter

November 21, 2007

Canada’s Labopharm has received a written response from the FDA regarding its appeal of the agency’s approvable letter for once-daily tramadol, an analgesic.

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 May approvable letter.

Labopharm said it plans to appeal to the next supervisory level at the FDA in coming weeks.