COSTA MESA, Calif. -- 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.
The FDA had asked Valeant to update the labeling when it purchased the drug from Eli Lilly & Company in 2004 and Valeant has been withholding launch of the product pending approval of the updated label.
Valeant Pharmaceuticals International (NYSE:VRX) is a global, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
Cesamet is a trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.
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