FDA Advisory Committee recommends VIVUS obesity drug
The US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee has recommended marketing approval of VIVUS's Qnexa for the treatment of obesity in adults.
The company has submitted new drug application (NDA) for Qnexa in October 2011.
Qnexa is an investigational drug candidate being developed to address weight loss, type 2 Diabetes and obstructive sleep apnea.
The product is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate.
VIVUS president Peter Tam said the company is pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa.
"We look forward to working with the FDA as they complete their evaluation," Tam added.
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