Arena
Pharmaceuticals ARNA and Eisai announced today that the
U.S. Food and Drug Administration (FDA) has approved BELVIQ (pronounced
BEL-VEEK) as an adjunct to a reduced-calorie diet and increased physical
activity for chronic weight management in adult patients with an initial body
mass index (BMI) of 30 kg/m2 ^ or greater (obese), or 27 kg/m2 or greater
(overweight) in the presence of at least one weight related comorbid condition
(e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes
the following limitations of use: The safety and efficacy of coadministration
of BELVIQ with other products intended for weight loss and the effect of
BELVIQ on cardiovascular morbidity and mortality have not been established.
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