Qnexa May Get Staged Launch After No Vote From Advisory Panel
Limited distribution could be a path to approval sooner, rather than later, for Vivus' obesity drug Qnexa following the Endocrinologic and Metabolic Drugs Advisory Committee's recommendation against approval July 15
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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.
Office of New Drugs Director John Jenkins reassured panel members of the agency’s ability to assess civil penalties or cite a drug for misbranding if sponsors fail to meet post-market study obligations.
Endocrinologic and Metabolic Drugs Advisory Committee also will weigh in on a teratogenicity risk management strategy for Vivus’ weight-loss drug during a Feb. 22 meeting.