The FDA has requested additional information to address concerns over potential adverse events. Valeant says that it plans to meet with the FDA promptly to discuss the rejection of its application.
The regulators asked Valeant to update the labeling when it purchased the drug from Eli Lilly in 2004 and Valeant has been withholding its US launch of the product pending approval of the updated label.
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 currently sells the drug in Canada.
Valeant discovers, develops, manufactures and markets products primarily in the areas of neurology, infectious disease and dermatology.