FDA Committee to Meet on Contrave Dec. 7, 2010

On December 7, 2010, the FDA Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss the safety and efficacy of new drug application (NDA) 20-0063, proposed tradename CONTRAVE™ (naltrexone HCl/bupropion HCl) extended-release tablets, manufactured by Orexigen Therapeutics, Inc., for the treatment of obesity and weight management, including weight loss and maintenance of weight loss in patients with an initial body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter with one or more risk factors (e.g. diabetes, dyslipidemia, or hypertension). The BMI is a measure of body weight (mass) based on a person’s weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient.

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