Labopharm continues to dispute FDA approvable letters

LAVAL, Quebec Labopharm Pharmaceuticals has announced that they will continue their dispute resolution process with the Food and Drug Administration over their controlled-release formulation of tramadol, a pain medication.

The acting director of the Office of Drug Evaluation II recently rejected the company’s request to overturn an approvable letter, which the FDA sent to Labopharm in May over the formulation of the drug.

The letter in May, said that Labopharm hadn’t demonstrated the efficacy of its once-daily tramadol formulation because the statistical methods used to analyze the data didn’t adequately address missing data related to subjects who dropped out of the clinical trials. The company said the agency changed its approval standards for the drug in the middle of the application process. The firm emphasized that it followed the special protocol assessment, and the trial met its endpoint.

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