Vivus Inc. (VVUS) has resubmitted a new drug application for its Qnexa obesity drug, aiming once more for the approval of the drug from the Food and Drug Administration. The FDA rejected Qnexa last year, asking for more information about the potential risk that one of Qnexa’s active ingredients, topiramate, could cause birth defects in babies born to women who take the drug. In response to the FDA concerns, Vivus agreed to conduct an analysis to assess fetal outcomes in offspring of women exposed to topiramate during the first trimester of pregnancy. Initial results of the study, titled “Fortress,” are due in December.
