Zydus Lifesciences Receives FDA Approval for Dasatinib Tablets

Zydus Lifesciences has obtained final approval from the U.S. Food and Drug Administration (FDA) to market Dasatinib tablets in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg strengths. Dasatinib is employed to treat Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia in adults and children. This clearance enhances Zydus' oncology portfolio and increases its U.S. market presence. The drug will be produced at the Ahmedabad-based SEZ unit of the company. As of March 2025, Zydus has 415 FDA approvals and has submitted 483 Abbreviated New Drug Applications since 2003-04, establishing it as a dominant player in the generic pharma space.
Source: CNBC TV18