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A synthetic version of the active ingredient in marijuana -- withdrawn from the U.S. market 17 years ago -- will be back on sale in two or three weeks as a prescription drug for vomiting and nausea caused by chemotherapy.
The U.S. Food and Drug Administration gave approval Monday for the resumption of sales of Cesamet, said manufacturer Valeant Pharmaceuticals International of Costa Mesa, Calif. The company bought the drug, also called nabilone, from Eli Lilly and Co. in 2004, the Associated Press reported.
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Valeant currently sells the drug in Canada. It was approved in the U.S. in 1985 but withdrawn in 1989 for commercial reasons, company president Wes Wheeler said. Since purchasing the drug from Eli Lilly, Valeant has revised the label and updated its manufacturing process, Wheeler said.
Cesamet is a synthetic version of tetrahydrocannabinol (THC), the active ingredient in marijuana. Synthetic THC acts on the brain in the same way as THC in marijuana. Cancer patients take the one-milligram Cesamet tablets twice daily before they have chemotherapy, and up to 48 hours after treatment, the AP reported.
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