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    FDA refuses to approve another diet drug

    By: Seeger Weiss LLP on November 14, 2010

    The agency sent a letter to the drugmaker raising a variety of concerns about Qnexa, according to Vivus Inc., of Mountain View, Calif., which had sought the drug’s approval. The letter does not bode well for the drug winning approval.

     

    From the Washington Post blog, The Checkup:

    The agency sent a letter to the drugmaker raising a variety of concerns about Qnexa, according to Vivus Inc., of Mountain View, Calif., which had sought the drug’s approval. The letter does not bode well for the drug winning approval.

    The move was expected, given that an FDA advisory panel had voted against the drug’s approval in July because of evidence it may have adverse side effects, including increasing the risks for birth defects during pregnancy.

    But the step is the latest in a series of setbacks in the effort to develop new weight-loss drugs. The FDA last week rejected approval of lorcaserin because of it appeared to cause tumors in rats. And earlier this month the agency forced the removal of the the drug Meridia from the market because it appears to increase the risk for heart attacks and strokes.

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