Xarelto Action Letter No Surprise; But Does FDA Want Data, REMS Or Both?
As anticipated, FDA answered Johnson & Johnson/Bayer's NDA for anticoagulant Xarelto (rivaroxaban) with a complete response letter May 28
As anticipated, FDA answered Johnson & Johnson/Bayer's NDA for anticoagulant Xarelto (rivaroxaban) with a complete response letter May 28