The FDA recently rejected the an indication for the use of rivaroxaban in patients with acute coronary syndrome.

FORBES: Xarelto Effective In Medically Ill Patients But At High Bleeding Cost

Superiority language in labeling might induce physicians to switch patients who are doing well on warfarin to rivaroxaban.

FORBES: FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

Rivaroxaban, like dabigatran etexilate, which NICE recently approved as an option for this indication, can benefit people with AF.

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The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto rivaroxaban to reduce the risk of stroke in people who have abnormal heart rhythm non-valvular atrial fibrillation.

FORBES: FDA Approves Xarelto

The single daily dose of rivaroxaban was also criticized.

FORBES: FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

In a sign of just how complicated it will be, the official American Heart Association press release on the presentation today at the AHA meeting only stressed that rivaroxaban was comparable to warfarin, not superior.

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Rivaroxaban is currently indicated in the US for stroke reduction in patients with atrial fibrillation, for the treatment and prevention of recurrence of deep venous thrombosis and pulmonary embolism, and for DVT prophylaxis after orthopedic surgery.

FORBES: Xarelto Effective In Medically Ill Patients But At High Bleeding Cost

The U.S. Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.

FORBES: Rivaroxaban Gains FDA Indications For The Treatment And Prevention Of DVT And PE