Labopharm once-daily tramadol "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Labopharm may still have a chance to get its once-daily tramadol product on the market by year end if it resopnds quickly to a Sept. 28 "approvable" letter and receives a Class 1 designation for its response. The firm did not disclose the issues cited in FDA's letter, but said no additional data will be needed to address them; the NDA was submitted Nov. 28, 2005 (1Pharmaceutical Approvals Monthly December 2005, In Brief)...
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