WASHINGTON Labopharm’s appeal of a second approvable letter from the Food and Drug Administration for a once daily formulation of its pain drug Tramadol has been rejected by the agency.
The director of the Center for Drug Evaluation and Research’s Office of New Drugs, John Jenkins, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements,” according to Labopharm.
The method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.
Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.