Article: Orlistat wins approval as OTC weight-loss drug: the thrice-daily drug blocks up to 25% of total fat absorption in the intestine, which is then excreted.(News)

Orlistat will soon be available to consumers without a prescription, making it the first weight-loss product available over the counter that has been recognized as safe and effective.

The approval of orlistat (Alli) by the Food and Drug Administration on Feb. 7 is notable because all other OTC weight-loss therapies--mainly dietary supplements and herbal products--have not received the agency's formal approval, said Dr. Charles Ganley, director of the FDA's division of OTC products.

Alli is approved only for users over age 18 years, but the agency did not impose any restrictions on its sale, such as requiring it to be held behind a counter.

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