Zydus Lifesciences gets USFDA nod for dasatinib tablets

Zydus Lifesciences (BSE: ZYDUSLIFE) announced that it has secured final approval from the United States Food and Drug Administration (USFDA) for its Dasatinib tablets, available in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg strengths. These tablets, a generic version of Sprycel, are indicated for treating Philadelphia chromosome-positive chronic myeloid leukemia in adults and Philadelphia chromosome-positive acute lymphoblastic leukemia. The company will produce these tablets at its Zydus Lifesciences Ltd (SEZ) facility in Ahmedabad. As of January 2025, annual sales for Dasatinib tablets reached $1807.7 million in the United States. With this approval, Zydus now holds 415 approvals and has filed 483 ANDAs since starting the filing process in FY2003-04.