FDA accepts VIVUS NDA filing for Qnexa with PDUFA set for April 2012
There was good news for US drugmaker VIVUS (Nasdaq: VVUS) in its long-running battle to get its weight-loss drug approved, in that the Food and Drug Administration (FDA) has now accepted for filing and review the New Drug Application for Qnexa (phentermine/topiramate) to treat obesity.
The company resubmitted the NDA last month (The Pharma Letter October 17) and follows an agreement reached earlier this year with officials from the FDA advisory panel on the filing strategy for Qnexa (TPL September 16).
The agency assigned a six-month, or class 2, review classification to the NDA, establishing April 17, 2012, as the Prescription Drug User Fee Act (PDUFA) target date. The FDA indicated that an advisory committee of the Division of Metabolism and Endocrinology Products (DMEP) will meet to discuss the Qnexa NDA in the first quarter of 2012.
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