FDA says Valeant's Cesamet 'nonapprovable' due to concerns about adverse events

By E. Janene Geiss

Philadelphia, Dec. 30 - Valeant Pharmaceuticals International said Friday that it has received a nonapprovable letter from the Food and Drug Administration for the company's application requesting labeling changes to its previously approved drug Cesamet (nabilone).

The FDA requested additional information to address concerns over potential class-related adverse events, according to a company news release.

Valeant said it plans to meet with the FDA promptly to discuss the details.

Cesamet was approved in 1985 for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.

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

The FDA had asked Valeant to update the labeling when it purchased the drug from Eli Lilly & Co. in 2004, and Valeant has been withholding launch of the product pending approval of the updated label.

Valeant is a Costa Mesa, Calif., research-based specialty pharmaceutical company that develops, manufactures and markets products primarily in the areas of neurology, infectious disease and dermatology.

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