Valeant Pharmaceuticals International Receives Non-Approvable Letter From FDA For Labeling Application Of Cannabinoid Cesamet(TM) (CII)

COSTA MESA, Calif.--(BUSINESS WIRE)--Dec. 30, 2005--Valeant Pharmaceuticals International (NYSE:VRX) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration for the company's application requesting labeling changes to its previously approved drug Cesamet (CII) (nabilone). The FDA requested additional information to address concerns over potential class related adverse events. Valeant plans to meet with the FDA promptly to discuss the details of the letter. Cesamet was approved in 1985 for the treatment of nausea and vomiting associated with cancer chemotherapy (CINV) in patients who have failed to respond adequately to conventional anti-emetic treatments. Valeant currently sells Cesamet in Canada, where the product has an 88 percent share of the cannabinoid market, according to IMS data from June 2005.