On February 11, 2007, the United States Food and Drug Administration (FDA)approved the diet drug Alli, also known as Orlistat, and previously available as the prescription drug Xenical, for over-the-counter sales.
According to MayoClinic.com, studies show that prescription strength orlistat (Xenical) helps users following a low-fat, low-calorie diet and exercise program lose an additional five to seven pounds in a year.
The safety and efficacy of Orlistat 60 mg was reviewed by an FDA joint advisory committee, which recommended approving the product for over-the-counter use by a vote of eleven to three.
Orlistat - This drug, sold most popularly under the name Xenical, is a fat inhibitor and is manufactured as both a prescription medication and an over-the-counter drug.
SB: GlaxoSmithKline Consumer Healthcare acquired exclusive over-the-counter marketing rights in the U.S. for Orlistat 60 mg from Roche Pharmaceuticals in July 2004.