FDA will take 3 more months to review Vivus drug
Vivus says FDA will take 3 more months to review obesity drug Qnexa, decision now due in July
MOUNTAIN VIEW, Calif. (AP) -- Drug developer Vivus Inc. says that regulators will take another three months to review the safety strategy on its proposed obesity drug Qnexa.
The company says the Food and Drug Administration is now expected to make a decision on Qnexa by July 17. Previously the agency was scheduled to return a decision by April 17. Vivus says the FDA extended its review because it needed more time to evaluate the risk evaluation and reduction strategy Vivus has proposed.
Vivus submitted that data to the FDA on Wednesday. Side effects associated with Qnexa include birth defects, heart palpitations, suicidal thoughts, and memory lapses.
Shares of the Mountain View, Calif., company dropped 5.5 percent, to $21.65 in after-hours trading.
