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01 Oct 2025
Admin
News Article

Lupin Receives FDA Approval for Rivaroxaban Oral Suspension

Lupin Limited, a global pharmaceutical company, announced that it has received FDA approval for its Abbreviated New Drug Application (ANDA) for rivaroxaban oral suspension, 1 mg/mL. The formulation is bioequivalent to Xarelto® oral suspension, 1 mg/mL, marketed by Janssen Pharmaceuticals, Inc.

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India, ensuring high-quality production for the U.S. market.

Indications

Rivaroxaban oral suspension is approved for use in pediatric patients:

Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to under 18 years, following at least 5 days of initial parenteral anticoagulant therapy.
Thromboprophylaxis in patients 2 years and older with congenital heart disease post-Fontan procedure.

This approval adds a critical oral anticoagulant option for pediatric patients, offering flexibility in dosing and administration for children unable to swallow tablets.

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