Valeant Pharmaceuticals International on Tuesday said regulators have approved its synthetic version of Cannabis to treat nausea associated with chemotherapy.
The approval by the Food and Drug Administration comes after the agency rejected Valeant’s request for a labeling change for the drug in December, delaying its launch.
The agency approved Valeant’s Cesamet to treat nausea and vomiting from chemotherapy in cancer patients who have not responded to other nausea treatments.
The company acquired Cesamet from Eli Lilly & Co in 2004. The drug is sold in Canada, where it holds the dominant share of the market, according to Valeant.
Late last year, regulators asked Valeant to update the drug’s labeling after Valeant bought it from 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.
