Drugs
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.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
FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury
5/26/2010Questions and Answers: Orlistat and Severe Liver Injury
5/26/2010FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli
FDA press release (5/26/2010)Weight-Loss Drugs and Risk of Liver Failure
FDA consumer updateOrlistat (marketed as Alli and Xenical): Labeling Change
MedWatch alert (5/26/2010)UPDATED Public Health Alert: Counterfeit Alli containing sibutramine
1/23/2010Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical) Issued 8/24/2009 Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
MedWatch alert (8/24/2009)
Labeling and Regulatory History from Drugs@FDA
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