Labopharm to appeal FDA decision on tramadol
LAVAL, Quebec Labopharm will appeal a decision by the Food and Drug Administration to withhold approval of the company’s once-daily formulation of the painkiller tramadol, according to the Canadian press.
The company will use the FDA’s dispute-resolution process to challenge the agency’s claim that it had not demonstrated that its tramadol product works as indicated. Labopharm had received a second approval letter in May from the FDA for the drug.
FDA’s dispute process permits decisions to be reviewed by various supervisors before proceeding through its chain of command to the Commissioner of Food and Drugs.