FDA sends non-approvable letter to Valeant

COSTA MESA, Calif., Dec. 30 (UPI) -- Valeant said Friday it got a non-approvable letter from the Food and Drug Administration on labeling changes for its drug Cesamet.

Valeant said the FDA issued the company a non-approvable letter saying Valeant cannot yet update the labeling of Cesamet, approved in 1985 for the treatment of nausea and vomiting associated with chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.

Valeant said the FDA has asked for additional information to address concerns over potential drug class-related adverse events.

Valeant said it plans to meet with the FDA promptly to discuss the details of the letter. Valeant has not yet marketed the product pending approval of the updated label.

The FDA had asked Valeant to update the labeling when it purchased the drug from Eli Lilly & Company in 2004.

Valeant said it currently sells Cesamet in Canada, where the product has an 88-percent share of the cannabinoid market, according to IMS data from June 2005.