BRIEF—FDA nod for Xarelto to help prevent blood clots in pediatric populations

The US Food and Drug Administration has approved German drug major Bayer’s Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism (VTE), or blood clots that form in the veins, and reduce the risk of VTE recurring in pediatric patients from birth to younger than 18 years who have received at least five days of injectable or intravenous treatment for blood clots.

The FDA also approved Xarelto to prevent blood clots in pediatric patients two years and older with congenital (present from birth) heart disease after the Fontan procedure, a type of open-heart surgery.

FDA approved Xarelto in tablet form in 2011; Xarelto as an oral suspension is a new dosage form the agency approved today. FDA previously approved Xarelto to treat, prevent, or reduce the risk of various blood clotting conditions in certain patient populations and for other uses.