FDA Again Delays Expanded Use Of Blood Thinner Xarelto

Law360, New York (March 5, 2013, 6:39 PM EST) -- The U.S. Food and Drug Administration has delayed for the second time a decision to expand use of Johnson & Johnson and Bayer AG's blood thinner Xarelto to allow for the treatment of acute coronary syndrome, amid safety concerns over the drug, J&J said Tuesday.

The FDA had sent a response letter to J&J unit Janssen Research & Development LLC, saying it needed answers to a number of unspecified questions related to a trial of the drug before it could consider approving the expansion, according to...
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