Tuesday, December 21, 2021

BAYER:U.S. FDA approves Xarelto™ to treat venous thromboembolism (VTE) and to prevent VTE in children

U.S. FDA approves Xarelto™ to treat venous thromboembolism (VTE) and to prevent VTE in children

Xarelto is the only Factor Xa anticoagulant FDA approved for pediatric patients and offers a flexible weight-based dosing / Xarelto is available in both oral tablet and liquid suspension formulations for use in appropriate children less than 18 years of age / Convenient liquid formulation advances standard of care for children; alleviates administration challenges found with injectable alternatives


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Berlin, December 21, 2021 – The U.S. Food and Drug Administration (FDA) has approved two pediatric indications for Xarelto™ (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of VTE and VTE related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.