Reuters: Global Markets: Vivus diet drug approval decision delayed 3 months

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Vivus diet drug approval decision delayed 3 months Apr 9th 2012, 21:43 Mon Apr 9, 2012 5:52pm EDT (Reuters) - U.S. health regulators have extended by three months their deadline for making an approval decision on Vivus Inc's (VVUS.O) diet drug Qnexa, the company said on Monday, marking the latest delay to bring a new obesity treatment to market. Vivus shares fell 6 percent after the delay was announced, slipping to $21.50 in extended trading from their Nasdaq close at $22.92. The Food and Drug Administration informed Vivus that it will decide whether to approve Qnexa by July 17 as it needs more time to review the company's risk evaluation plan for the drug. The previous FDA action date for Qnexa had been April 17. Vivus's Qnexa is one of three experimental new weight loss drugs seeking FDA approval after initial rejections by the agency. After an advisory panel to the FDA in February voted overwhelmingly to recommend approval of Qnexa, saying that its benefits outweighed the risks, hopes that the first new obesity treatment would be approved for sale in the United States in more than a decade soared -- along with Vivus's share price. But the FDA requested a Risk Evaluation and Mitigation Strategy (REMS) plan from the company, which the agency considers a major amendment to the approval application requiring further review time. "The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February," Vivus Chief Executive Leland Wilson said in a statement. "We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans," Wilson added. (Reporting By Bill Berkrot; Editing by Gary Hill, Bernard Orr) Link this Share this Digg this Email Reprints

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