Home > Newsletters > RxTrials Institute Drug Pipeline Alert > FDA Responds to Labopharm’s Appeal of Tramadol Approvable Letter
RxTrials Institute Drug Pipeline Alert
Nov. 26, 2007 | Vol. 5 No. 230
FDA Responds to Labopharm’s Appeal of Tramadol Approvable Letter
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.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.