Labopharm once-daily tramadol goal date is June 19
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The user fee goal for Labopharm's once-daily tramadol formulation is June 19, the Canadian firm says Jan. 16. The new goal date reflects Labopharm's December complete response to a Sept. 28, 2006, "approvable" letter (1Pharmaceutical Approvals Monthly October 2006, In Brief). The response contains additional analyses of existing data but no new data, the firm said. Labopharm is also appealing the letter. The June 19 user fee goal could put Labopharm behind Cipher's competing extended-release tramadol NDA, which has a May 1 action date...