The committee will discuss supplemental new drug application (sNDA) 202439/S-002, rivaroxaban, trade name XARELTO 2.5 milligram tablets, submitted by Janssen Pharmaceuticals, Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after suffering acute coronary syndrome [ST elevation myocardial infarction, non-ST elevation myocardial infarction, or unstable angina].
January 16, 2014 8:00 a.m. to 5:00 p.m.: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Where:
FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The committee will discuss supplemental new drug application (sNDA) 202439/S-002, rivaroxaban, trade name XARELTO 2.5 milligram tablets, submitted by Janssen Pharmaceuticals, Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after suffering acute coronary syndrome [ST elevation myocardial infarction, non-ST elevation myocardial infarction, or unstable angina].
Please click HERE for the current roster of the Cardiovascular and Renal Drugs Advisory Committee.
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