FDA Overrules Staff To Broaden Approval Of J&J’s Xarelto

Law360, New York (November 4, 2011, 7:37 PM EDT) -- The U.S. Food and Drug Administration on Friday approved Johnson & Johnson and Bayer AG's blood thinner Xarelto for treating abnormal heart rhythm after the agency's own staff refused to recommend the approval amid safety concerns.

Abnormal heart rhythm, or atrial fibrillation, can cause blood clots and in turn disabling strokes, according to Norman Stockbridge, director of the FDA's division of cardiovascular and renal products. “This approval gives doctors and patients another treatment option for a condition that must be managed carefully,” he said in a...
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