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Qnexa REMS Should Deter Off-Label Use Of Components, But Not Place Undue Burden

 
• By Cathy Dombrowski

The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving the combination of phentermine and topiramate for weight loss during its second review of Vivus’ application.

FDA’s approach to risk management for Vivus Inc.’s weight-loss therapy Qnexa, a combination of phentermine and topiramate, reflects concern about affecting medical use of the two components, which currently are marketed individually.

Topiramate is available as Janssen Pharmaceuticals Inc.’s Topamax and generics to treat epilepsy and for migraine prophylaxis, while phentermine is sold for short-term use as an appetite suppressant.

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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