23 June 2021 - Application seeks two paediatric indications, including an age-appropriate new weight-based oral suspension formulation.

Bayer´s development partner, Janssen has submitted a new drug application to the U.S. FDA for the use of the oral anti-coagulant Xarelto (rivaroxaban) in pediatric patients. 

The new drug application seeks two paediatric indications:

• Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in paediatric patients from birth to less than 18 years of age after at least 5 days of initial parenteral anti-coagulant treatment
• Thromboprophylaxis in paediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure

Read Bayer press release