Mumbai, Oct. 1 -- The product is a generic version of Xarelto for Oral Suspension, 1 mg/mL, originally developed by Janssen Pharmaceuticals, Inc.

The approved product is bioequivalent to the reference listed drug and will be manufactured at Lupin's facility in Chhatrapati Sambhajinagar, India.

Rivaroxaban for Oral Suspension is indicated for the treatment of venous thromboembolism (VTE) and for reducing the risk of recurrent VTE in pediatric patients from birth to less than 18 years of age, following at least five days of initial parenteral anticoagulant therapy. It is also approved for thromboprophylaxis in pediatric patients aged two years and older with congenital heart disease who have undergone the Fontan procedure.

According to I...