USFDA15 May 2025, 07:21 pm
Biocon Pharma Receives US FDA Approval for Rivaroxaban Tablets
AI Summary
Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received approval from the US FDA for its ANDA for Rivaroxaban Tablets USP in 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. This approval will further strengthen Biocon’s portfolio of vertically integrated drug products.
Key Highlights
- Biocon Pharma received US FDA approval for Rivaroxaban Tablets USP
- The approval is for strengths of 2.5 mg, 10 mg, 15 mg and 20 mg
- Rivaroxaban is used in the treatment of deep vein thrombosis and pulmonary embolism
- The approval will strengthen Biocon’s portfolio of vertically integrated drug products
- The information is available on Biocon’s website