Canada's Labopharm says that the FDA did not reverse its decision regarding an approvable letter for once-daily Tramadol, but it noted an encouraging new approach to a statistical method being used in a new analysis of the data. Also encouraging was the agency's request for a new meeting before Labopharm resubmits its application for approval. The company had appealed the FDA's conclusion that researchers couldn't demonstrate efficacy because the data omitted the outcomes for volunteers who had dropped out of the study.
"We are encouraged by the FDA's recent communication and are currently evaluating the proposal outlined in the letter," Labopharm's president and chief executive James Howard-Tripp, said in a release.
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