FDA Extends Review Of Weight-Loss Drug.

The Wall Street Journal  (4/10, Fitzgerald, Subscription Publication) reports the US Food and Drug Administration will extend its review an extra three months for a target date of July 17 for Vivus Inc's weight-loss drug phentermine and topiramate [Qnexa].

        The company "said in a statement the extension gives the agency more time to review the safety strategy for the drug -- including the patients who qualify to take it and those who don't," USA Today  (4/10, Hellmich) reports. "Research shows it helps reduce diabetes and lowers blood pressure and other cardiovascular risk factors." However, "critics point out that Qnexa caused an increased heart rate in some patients who took a high dose, and increased the risk of cleft lip in the newborns of expectant mothers who took the drug."

        The AP  (4/10, Perrone, Seaman) reports, "Vivus said it submitted new materials for Qnexa's risk management plan to the FDA last Wednesday." The company "has asked the FDA to approve Qnexa for patients who are obese and who have related health problems like high blood pressure or type 2 diabetes."

        Bloomberg BusinessWeek  (4/10, Edney) reports, "The date was extended after Vivus submitted, at the Food and Drug Administration's request, a risk evaluation and mitigation strategy, the company said today in a statement." Vivus said, "The extension is standard to provide time for a full review." Also covering the story is Reuters  (4/10).