Valeant Pharmaceuticals International said Friday that the Food and Drug Administration quashed its request for a labeling change for Cesamet, delaying the launch of the anti-vomiting drug.
Costa Mesa-based Valeant said that the FDA wanted additional information on potential safety problems with the drug. The company said it had requested a meeting with FDA officials to address the issues, but didn’t know when they would meet.
Regulators had asked Valeant to update the drug’s labeling after Valeant bought it last year from Indianapolis-based Eli Lilly & Co.
Cesamet is a cannabinoid, or synthetic chemical, that is based on tetrahydrocannabinol, the active ingredient in marijuana known as THC. It’s used to treat nausea and vomiting in cancer chemotherapy patients who don’t respond to conventional treatments.
Valeant sells Cesamet in Canada, where it makes up 88% of the cannabinoid market, according to IMS Health.
