April 10, 2012
Company news: Vivus
Vivus announced Tuesday that the FDA has pushed back the review date for its weight-loss drug to July 17. The phentermine-topiramate combination, which got the thumbs-up from an FDA advisory panel in February, was slated to go for a full agency evaluation April 17. The company said in a statement that the FDA wanted more time to review the Risk Evaluation and Mitigation Strategy Vivus had proposed. That strategy is an expansion of the one Vivus outlined in February. The initial Vivus proposal recommended patient surveys, a patient-provider agreement, pharmacy certification and limiting the drug's distribution to 10 or fewer mail-order pharmacies, among other measures. The drug's risks include memory loss and birth defects, which were among the reasons for the agency's 2010 rejection of the drug.