Tag archive for ‘JNJ’
FDA Cardiovascular and Renal Advisory Committee Goes Against FDA View and Recommends Approval of Xarelto
The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]