Biocon Pharma gets USFDA nod for deep vein thrombosis drug Rivaroxaban
Bangalore: Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received approval for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP from the United States Food and Drug Administration (US FDA), for strengths of 2.5 mg, 10 mg, 15 mg and 20 mg.
Rivaroxaban is a prescription medication used in the treatment of deep vein thrombosis and pulmonary embolism, to reduce the risk of stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation.
The approval will further strengthen Biocon’s portfolio of vertically integrated drug products.
Read also: Biocon Biologics secures multiple market access agreements in US for Yesintek
Medical Dialogues team has recently reported that Lupin, Alembic Pharma and Aurobindo Pharma have also received the US FDA approval for Rivaroxaban Tablets in different strengths.
-Read also: Lupin Rivaroxaban Tablets approved by USFDA
Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
Read also: Biocon Biologics receives EMA Committee positive opinions for Biosimilar Denosumab for bone health
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