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FDA approves Valeant Pharmaceutical's Synthetic Cannabis (THC) Drug

Drug Information

Seventeen years after it was withdrawn from U.S. markets, a synthetic version of the active ingredient in marijuana is going back on sale as a prescription treatment for the vomiting and nausea that often accompanies chemotherapy, its manufacturer said Tuesday.

Valeant Pharmaceuticals International hopes to begin selling Cesamet in two to three weeks, company President Wes Wheeler said.

The Costa Mesa, Calif., company received Food and Drug Administration approval Monday to resume sales of the drug, which it bought from Eli Lilly and Co. in 2004. Valeant currently sells the drug, also called nabilone, in Canada.

Lilly received FDA approval for nabilone in 1985 but withdrew it from the market in 1989 for commercial reasons, Wheeler said.

The drug will compete with Marinol, made by Belgium-based Solvay SA. Marinol is another synthetic version of tetrahydrocannabinol, the active ingredient in marijuana that's more commonly known as THC. It also received FDA approval in 1985.

Cesamet is a Schedule II drug, meaning it has a high potential for abuse. It is meant to be taken before cancer patients undergo chemotherapy and up to 48 hours after treatment.