Zydus Lifesciences secures US FDA approval for generic Dasatinib tablets in the US

Zydus Lifesciences Ltd on Wednesday (March 5) said it has received final approval from the United States Food and Drug Administration (USFDA) to market Dasatinib tablets in multiple strengths —20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.”Zydus has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. (USRLD: Sprycel® Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg),” according to a stock exchange filing.
The drug is a generic version of Sprycel tablets, which had annual US sales of $1.81 billion, according to IQVIA MAT data as of January 2025.
Dasatinib is used to treat newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
Also Read: Zydus Life to develop combination vaccine against shigellosis and typhoid for childrenIt is also prescribed for adults with chronic, accelerated, or blast phase Ph+ CML and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in cases of resistance or intolerance to prior therapies. Zydus will manufacture the tablets at its Ahmedabad SEZ facility.

With this approval, Zydus has secured 415 regulatory clearances and has filed 483 (As of December 31, 2024) Abbreviated New Drug Applications (ANDAs) since FY 2003-04.

Shares of Zydus Lifesciences Ltd ended at ₹887.95, up by ₹16.15, or 1.85%, on the BSE.

Also Read: USFDA clears Zydus Lifesciences’ Ahmedabad facility with zero observation