Pradaxa, also known as dabigatran, was first to market, getting approved in October 2010 for patients with atrial fibrillation. Xarelto has since been approved for patients with atrial fibrillation and for preventing blood clots after hip or knee replacement surgery. But J&J said last week the FDA denied its request to expand approval of Xarelto to prevent life-threatening blood clots in patients with acute coronary artery disease, and it expects to work with them to address the questions as quickly as possible.
AP Business Writer Tom Murphy in Indianapolis contributed to this story.
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma
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