NOTIFICATION TO STOCK EXCHANGE
COMPANY STATEMENT
This is to inform you that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received final approvals for its following ANDAs from the U.S. Food and Drug Administration (U.S. FDA):
Lenalidomide Capsules, 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, 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. It is also used to treat Ph+CML and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) in adults after other medicines (eg, imatinib) or treatments did not work well. Dasatinib is also used in combination with chemotherapy to treat newly diagnosed Ph+ALL in children 1 year of age and older.
Biocon Pharma Limited 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.
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