FDA Adds Three Months to Review Time For Weight Loss Drug Qnexa, Company Says

The Food and Drug Administration will take more time before making an approval decision on the weight loss drug Qnexa (phentermine/topiramate), the drug’s maker said April 9.

Vivus, based in Mountain View, Calif., said FDA informed the company of an extended Prescription Drug User Fee Act (PDUFA) date for review of the Qnexa new drug application (NDA), from April 17 to July 17. The three-month extension “is a standard extension period,” the company said, adding that on April 4, following the FDA’s request, Vivus submitted the Qnexa risk evaluation and mitigation strategy (REMS), which was considered a major amendment to ...