Biocon arm gets USFDA nod for cancer, deep vein thrombosis drugs

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.

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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.

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