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" ... Compare this to the question asked at a recent Cardiovascular AdComm – “Should rivaroxaban be approved for use in ACS?” Simple, to the point; no caveats; no (mis)leading the panel. To the first confusing question at the eteplirsen AdComm, the panel voted seven to six against; to the second, it voted seven to three against. Neither question addressed approvability, as mandated in the statute – AdComms are convened “for the purpose of providing…recommendations to the Secretary regarding…approval for marketing of a drug…” ... "
" ... Rivaroxaban is already approved in Europe for the prevention of VTE following hip or knee replacement surgery. Bayer said that approval for the new indications would make rivaroxaban the first new oral anticoagulant in the EU with all three indications. ... "
" ... The FDA today expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of recurrent DVT and PE. ... "