Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received final approvals from the U.S. Food and Drug Administration (U.S. FDA) for multiple Abbreviated New Drug Applications (ANDAs), further strengthening its portfolio of complex drug products.
The approvals include Lenalidomide Capsules in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Lenalidomide is widely used for treating multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia related to myelodysplastic syndromes (MDS) in adults.
Additionally, Biocon Pharma has secured FDA clearance for Dasatinib Tablets in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg strengths. Dasatinib is prescribed for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in adults and children over one year old. It is also used in treating Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) in both adults and pediatric patients.
The company has also received tentative FDA approval for its ANDA of Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. Rivaroxaban is an anticoagulant used for treating deep vein thrombosis (DVT), pulmonary embolism, and reducing the risk of stroke in patients with nonvalvular atrial fibrillation.
These regulatory milestones bolster Biocon’s presence in the U.S. generics market and reinforce its capabilities in developing and manufacturing high-value, complex drug formulations.
