Wednesday, May 23, 2012

Reuters: Regulatory News: US FDA advisers rebuff J&J/Bayer Xarelto heart drug

Reuters: Regulatory News
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US FDA advisers rebuff J&J/Bayer Xarelto heart drug
May 23rd 2012, 20:23

SILVER SPRING, Md. | Wed May 23, 2012 4:23pm EDT

SILVER SPRING, Md. May 23 (Reuters) - A U.S. advisory panel rebuffed Johnson & Johnson's blood thinner, meant to reduce the risk of new heart attacks and strokes in people with heart problems.

A panel of outside experts to the Food and Drug Administration voted 6 to 4 on Wednesday that Xarelto should not be approved for people with acute coronary syndrome. J&J developed the drug in partnership with German drugmaker Bayer AG .

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by the end of June.

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