October 25, 2025

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Lupin bags USFDA approval for Rivaroxaban for Oral Suspension for thromboprophylaxis in pediatric patients

Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban for Oral Suspension, 1 mg/mL which is bioequivalent to Xarelto for Oral Suspension, 1 mg/mL of Janssen Pharmaceuticals, Inc. In addition to the oral suspension approval, Lupin received approval for its ANDAs for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP in May. Read also:Lupin Rivaroxaban Tablets approved by USFDA

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