RARITAN, N.J., June 28, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the supplemental New Drug Application (sNDA) for XARELTO® (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS). "We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are in ongoing discussions with the FDA regarding this sNDA," said Dr. Christopher Nessel, Vice President, Cardiovascular Franchise Medical Leader at Janssen. This sNDA is based on results from the 15,526-patient pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa...
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