Friday, June 28, 2013

Reuters: Regulatory News: Bayer says FDA requests more data on Xarelto for stent patients

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Reuters: Regulatory News
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Bayer says FDA requests more data on Xarelto for stent patients
Jun 28th 2013, 12:49

FRANKFURT, June 28 | Fri Jun 28, 2013 8:49am EDT

FRANKFURT, June 28 (Reuters) - Bayer said the U.S. Food and Drug Administration has put on hold a decision over the use of anti-clotting pill Xarelto to prevent stent thrombosis in patients suffering from acute coronary syndrome, requesting more information.

Bayer said on Friday it was confident that together with development partner Johnson & Johnson it can address the questions in the FDA's so-called "complete response letter".

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