1.24.2006

First OTC Weight Loss Drug Approved

Two committees that advise the Food and Drug Administration yesterday voted to support GlaxoSmithKline's effort to bring the first nonprescription weight-loss drug to the market.

Committee members voted 11-3 to support taking a lower-dose version of the prescription drug Xenical over the counter, saying the potential benefits of having an alternative to unproven dietary supplements outweigh the risks.

The ultimate decision now rests with Food and Drug Administration officials. But George Quesnelle, president of Glaxo's North American Consumer Products division in Moon, said the company expects to be selling its product later this year.

Glaxo anticipates that 5 million to 6 million people per year will purchase the drug, which will be sold under the name Alli.

"We look forward to working with the FDA to gain final approval," Mr. Quesnelle said. "We're excited by the potential to provide consumers with an FDA-approved over-the-counter option that provides gradual but meaningful weight loss."


With the side effect of diarrhea, and over 5 million interested in the drug, that's a lot of trips to the bathroom!


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