New Indication for Rivaroxaban Approved By FDA – Drug for nerve pain boosts high for opioid abusers.

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A new indication for Janssen’s rivaroxaban (Xarelto) has been approved by FDA officials.

First approved by the FDA in 2011, the oral anticoagulant is now indicated for reducing the risk of major cardiovascular (CV) events, such as death, myocardial infarction (MI), and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). The agency’s approval makes Xarelto the first and only Factor Xa inhibitor with the FDA’s backing for patients living with these conditions, according to Janssen.

“Despite the use of guideline-recommended therapies, patients with chronic CAD and/or PAD remain at risk of having a devastating and irreversible CV event,” said Paul Burton, MD, PhD, FACC, and Vice President of Medical Affairs, Internal Medicine, Janssen Scientific Affairs, LLC, in a prepared statement. “The new Xarelto vascular 2.5mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD.”

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