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  1. Drug Safety and Availability

Orlistat (marketed as Alli and Xenical) Information

Orlistat (marketed as Alli and Xenical) Information

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

Related Information

Labeling and Regulatory History from Drugs@FDA