FDA Panel Backs Astellas Bladder Drug Despite Concerns

Law360, New York (April 5, 2012, 7:50 PM EDT) -- In a split vote Thursday, a U.S. Food and Drug Administration advisory panel recommended approving an Astellas Pharma US Inc. bladder-control drug despite several panelists' reservations about the drug's effectiveness and its ties to increased heart and liver problems.

In a 7-4 vote, with one member abstaining, the FDA's advisory committee for reproductive health drugs found that the overall risk-benefit analysis supported the approval of Astellas' mirabegron. But many of the panelists still expressed concerns over the drug's risks, including panelists who voted to recommend approval....
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