Labopharm requests FDA meeting on tramadol NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Labopharm is requesting another meeting with FDA to discuss the NDA for its once-daily formulation of tramadol. "Should Labopharm and the agency fail to mutually agree on a path forward toward final regulatory approval, or should the FDA not grant the meeting within the next 30 days, Labopharm plans to appeal the FDA's current decision through the … formal dispute resolution process," the company announces Sept. 24. Labopharm's tramadol has received two "approvable" letters - in September 2006 and May 2007 (1Pharmaceutical Approvals Monthly, June 2007, In Brief). So far the company has responded with additional data analyses. In June, Labopharm indicated that the problems have involved statistical analysis issues, and that if the existing data did not satisfy the statistical requirements the firm would have to generate new data in an additional Phase III trial. Formal dispute resolution cannot be initiated while an application is under review...
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