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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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