Biocon has received tentative approval of its ANDA for Dasatinib tablets from the USFDA, for strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. This product is indicated for use in the treatment of Philadelphia chromosome positive chronic myeloid leukemia in adults.
It is also used to treat Philadelphia chromosome positive acute lymphoblastic leukemia in adults with resistance or intolerance to prior therapy. The approval will further strengthen 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.
