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Source: Forbes.com Healthcare News
Condition: Thrombosis
Drug: New Drug Applications
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FDA Once Again Rejects New Indication For Johnson & Johnson's Xarelto
The third time wasn't the charm. The FDA today turned turned down-- for the third time-- the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA-- for the second time-- turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.
Source: Forbes.com Healthcare News - February 14, 2014 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
