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Biocon’s arm gets USFDA’s nod for Lenalidomide Capsules, Dasatinib Tablets, Rivaroxaban Tablets

05 Mar 2025 Evaluate

Biocon’s wholly owned subsidiary -- Biocon Pharma has received final approvals for its Abbreviated New Drug Applications (ANDAs) from the United States Food and Drug Administration (USFDA) for its Lenalidomide Capsules and Dasatinib Tablets. Lenalidomide Capsules are in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg strengths. Lenalidomide is a medication used to treat types of multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia in myelodysplastic syndromes (MDS) in adults.

Dasatinib Tablets are in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg strengths. Dasatinib is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adults and children of 1 year of age and older.

Biocon Pharma also received tentative approval of its ANDA for Rivaroxaban Tablets USP, in 2.5 mg, 10 mg, 15 mg and 20 mg strengths. Rivaroxaban is used in the treatment of deep vein thrombosis and pulmonary embolism to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, etc. These approvals further add to Biocon’s portfolio of vertically integrated, complex drug products.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.


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