30 Sep 2025 | 3 Mins Read
Lupin receives FDA approval for pediatric Rivaroxaban use
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Lupin Limited received US FDA approval for its Abbreviated New Drug Application for Rivaroxaban for Oral Suspension, 1 mg/mL, which is bioequivalent to Xarelto. The product treats venous thromboembolism in pediatric patients and thromboprophylaxis in those with congenital heart disease. Estimated annual US sales are $11 million.