Bayer says FDA rejects wider use of Xarelto drug

FRANKFURT Fri Feb 14, 2014 8:29am EST

FRANKFURT Feb 14 (Reuters) - U.S. health regulators have declined to approve a proposed wider use of Bayer and Johnson & Johnson's anti-clotting drug Xarelto, Bayer said on Friday.

The companies had sought approval by the U.S. Food and Drug Administration (FDA) to widen the use of the oral drug to also reduce the risk of thrombotic cardiovascular events and stent thrombosis in patients with Acute Coronary Syndrome (ACS).

So far, Xarelto is mainly given to prevent strokes in the elderly, among other approved uses.

An advisory panel to the FDA concluded in January that Xarelto should not be cleared for the extended use.

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