The Janssen Pharmaceutical Companies of Johnson & Johnson announced on Monday that it has received approval from the United States Food and Drug Administration (FDA) for two paediatric indications for XARELTO (rivaroxaban) to treat venous thromboembolism (VTE or blood clots) and to decrease the risk of recurrent VTE in patients from birth to less than 18 years after around five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.

The company said that the product is the only FDA-approved direct oral anticoagulant for primary prevention of clots in paediatric patients subsequent to the Fontan procedure and the only direct oral anticoagulant in the United States to provide an oral suspension formulation for flexible, body weight-adjusted dosing options for paediatric patients.

The oral suspension formulation is to be administered via a colour-coded dosing device that was intended to help decrease dosing errors and is likely to become available in the United States for paediatric patients in mid-January 2022. Presently, the oral tablets are offered in the United States for appropriate paediatric patients.