Janssen responds to FDA Complete Response Letter for Xarelto for Acute Coronary Syndrome - 09-Sep-2012
Janssen Research & Development, LLC has submitted its reply to the Complete Response Letter from the FDA for the use of Xarelto (rivaroxaban) 2.5 mg twice daily in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS). The submission includes the information requested by the FDA in its letter to Janssen Research & Development on June 21, 2012. In addition, the supplemental New Drug Application (sNDA) for the use of rivaroxaban, in combination with standard antiplatelet therapy, to reduce the risk of stent thrombosis in patients with ACS has been resubmitted. Data from the ATLAS ACS 2-TIMI 51 trial support both filings
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