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Sep 10, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Xarelto rivaroxaban regulatory update

Johnson & Johnson submitted a response to an FDA complete response letter for an sNDA for Xarelto rivaroxaban to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS). FDA issued the letter in June after the Cardiovascular and Renal Drugs Advisory Committee voted 6-4 against recommending approval of Xarelto in the indication....

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