EMA agrees more time for Vivus to prepare for Qnexa oral hearings
US drug developer Vivus (Nasdaq: VVUS) says that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has rescheduled the decision process on the Marketing Authorization Application for its Qnexa (phentermine/topiramate), an investigational drug for the treatment of obesity.
Approval has also been held up by the US Food and Drug Administration, which has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application for Qnexa from April 17 to July 17, 2012 (The Pharma Letter April 10).
Hearing now scheduled for September
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