Reuters: Regulatory News: US FDA staff cite missing data for J&J's Xarelto

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US FDA staff cite missing data for J&J's Xarelto May 21st 2012, 12:38 WASHINGTON | Mon May 21, 2012 8:38am EDT WASHINGTON May 21 (Reuters) - U.S. drug reviewers said Johnson & Johnson's blood thinner Xarelto appeared to reduce the risk of new heart attacks and strokes in people with heart problems, but missing data raised doubts about whether the drug actually worked. The U.S. Food and Drug Administration staff reviewed the drug ahead of an advisory panel of outside experts, which will vote on whether to recommend the drug on Wednesday. The FDA usually follows panel recommendations, although it is not required to, and is due to make a final decision on Xarelto by the end of June.

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