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Janssen Reports Submission of NDA to the US FDA for Xarelto (rivaroxaban) to Prevent and Treat Blood Clots in Children

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Janssen Reports Submission of NDA to the US FDA for Xarelto (rivaroxaban) to Prevent and Treat Blood Clots in Children

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  • The application is based on two studies i.e P-III EINSTEIN-Jr & UNIVERSE. The P-III EINSTEIN-Jr study evaluates Xarelto in 500 children in a ratio (2:1) aged birth to 17yrs. with previously diagnosed VTE- following 5 days of initial parenteral anticoagulation treatment
  • The P-III UNIVERSE study evaluates Xarelto in children aged 2-8yrs. with congenital heart disease who have undergone the Fontan procedure. Xarelto would be a body weight-adjusted dose with an oral suspension formulation or tablets for both indications
  • If approved- Xarelto will be the first and only oral Factor Xa inhibitor indicated in the US for pediatric patients

  Ref: J&J | Image: Janssen 

Click here to­ read the full press release 

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