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.
January 16, 2014 8:00 a.m. to 5:00 p.m.: Cardiovascular and Renal Drugs Advisory Committee Meeting
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 to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
You can access the current roster of the Cardiovascular and Renal Drugs Advisory Committee HERE.
Please click HERE to access the original meeting announcement for this product.
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