Vivus says FDA has delayed Qnexa PDUFA date
The US Food and Drug Administration has advised informed USA-based rug developer Vivus (Nasdaq: VVUS) of an extended Prescription Drug User Fee Act (PDUFA) date for its review of the weight-loss drug candidate Qnexa (phentermine/topiramate) New Drug Application from April 17 to July 17, 2012.
The company’s shares dropped 8.2% to $21.03 in extended trading on Monday, despite Vivus saying the three-month extension is a standard extension period, as well as a 20 against two advisory panel vote recently to approve the drug (The Pharma Letter February 23).
Newly-submitted REMS considered a major NDA amendment
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