Biocon arm gets USFDA nod for cancer, deep vein thrombosis drugs
Bangalore: Biocon Limited has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received final approvals for its Abbreviated New Drug Applications (ANDAs) for Lenalidomide Capsules, Dasatinib Tablets from the U.S. Food and Drug Administration (U.S. FDA).
Lenalidomide Capsules have received approval for 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 have received approval for 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.
The Company has 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.
Read also: Biocon launches Liraglutide for diabetes, obesity in UK
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company. The Company has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.
