Glaxo still expected to sell weight-loss drug OTC

April 17, 2006

The FDA declined to allow GlaxoSmithKline to sell the weight-loss drug Xenical (orlistat) without a prescription, but the company said it still expects to introduce an OTC version of the drug by the end of the year.

The FDA declined to allow GlaxoSmithKline to sell the weight-loss drug Xenical (orlistat) without a prescription, but the company said it still expects to introduce an OTC version of the drug by the end of the year. Glaxo said it received a so-called approvable letter from the FDA, but did not say what the FDA would require in order to allow orlistat to be sold OTC. The company plans to market the drug under the name Alli. Meanwhile, the consumer group Public Citizen wants the FDA to ban orlistat because it claims that the obesity treatment has been linked to precancerous lesions in the large intestine.

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