Labopharm appeals FDA letter on tramadol

Labopharm said its response includes additional analysis of its existing data. The company suggested that it had addressed all of the matters raised by the FDA. Labopharm has appealed the action taken by utilizing the formal dispute resolution process.

“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 US,” said James Howard-Tripp, president and CEO of Labopharm.

The FDA resolves issues concerning scientific, including medical, disputes and procedural, including administrative, disputes that arise during the drug development, new drug review, generic drug review, and post marketing oversight processes, said Labopharm.