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Title: FDA Approves Labeling for Use of Xenical (Orlistat) in Management of Obesity in Adolescents

"FDA Approves Labeling for Use of Xenical (Orlistat) in Management of Obesity in Adolescents"

NEW YORK, NY -- December 16, 2003 -- The FDA has approved labeling for use of Xenical® (orlistat) in the management of obese adolescents, aged 12 to 16 years. Overweight and obesity has reached epidemic proportions in the United States. In fact, 15% of adolescents in the U.S. are currently obese and 30% are overweight. Now, with the first weight-loss medication approved by the FDA with labeling for use in the management of obese adolescents, these patients have a new option. Adolescents who are obese are at greater risk of being obese as adults and of developing serious health problems, including type 2 diabetes and heart disease, and have an increased risk of mortality. This is the first approval of its kind for a prescription weight-loss treatment. Approved by the FDA in April of 1999 as a weight-loss treatment for adults, there have been more than 16.7 million patient treatments with Xenical worldwide. SOURCE Roche

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