Labopharm responds to FDA approvable letter on tramadol

Canada's Labopharm says that it has submitted a complete response to the approvable letter issued by the US Food and Drug Administration for its once-daily formulation of tramadol. The firm's response includes additional analyses of existing data. In its response, Labopharm believes it has addressed all of the matters raised by the FDA in the approvable letter. Upon acceptance for review of the response, the FDA will assign an action date under the Prescription Drug User Fee Act.

The company has concurrently appealed the action taken by the FDA in its approvable letter utilizing the Formal Dispute Resolution process. Labopharm received the approvable letter on September 28, following submission of its New Drug Application on November 28, 2005.

"Based on discussions with the FDA and our regulatory advisors, we believe that this two-pronged approach will provide the most expeditious path forward as we pursue final regulatory approval in the USA," said James Howard-Tripp, chief executive of the firm.