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.
In contrast, alli is 60 mg Orlistat, an over-the-counter (OTC) program indicated for weight loss in overweight adults who follow a reduced-calorie, low-fat diet.
Xenical is prescription orlistat, a 120 mg capsule indicated for the treatment of obesity in patients who require the supervision of a physician.
The drug, called Orlistat, will be sold under the brand name alli, and is designed to help people lose more weight than with dieting alone.
Sibutramine, Meridia's active ingredient and Orlistat found in Xenical are both chemically-based compounds.
We filed an application to make Orlistat 60 mg available over-the-counter, with the brand name Alli.