Xenical (orlistat 120 mg) was approved as a prescription by the FDA in 1999 for the management of obesity in combination with a low calorie diet and to reduce the risk of regaining weight after previous weight loss. In 2007, Alli (orlistat 60 mg) was approved for OTC use for weight loss in overweight adults 18 years of age and older, along with a low-calorie, low-fat diet.

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Labeling and regulatory history from Drugs @ FDA