Tuesday, January 3, 2012

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee Meeting on February 22, 2012 from 8:00 a.m. to 5:00 p.m.

Agenda: On February 22, 2012, the committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

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