Qnexa May Get Staged Launch After No Vote From Advisory Panel
Executive Summary
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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FDA Says Qnexa Needs CV Outcome Trial, Asks Cmte. To Consider Pre- Or Post-Approval Timeframe
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.