Zydus Lifesciences rises after receiving US FDA approval for leukemia treatment drug Dasatinib

Zydus Lifesciences added 3.33% to Rs 917.10 after the company said that it has received final approval from the United States Food and Drug Administration (US FDA) to manufacture generic Dasatinib Tablets in multiple strengths.

The approved drug is a generic version of Sprycel Tablets.

Dasatinib is used to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in newly diagnosed adults, as well as in adults with resistance or intolerance to prior therapies, including imatinib. Dasatinib is also indicated for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults with resistance or intolerance to prior therapy.

The Dasatinib tablets will be manufactured at Zydus Lifesciences' facility in Ahmedabad.

According to IQVIA MAT January 2025 data, Dasatinib tablets generated annual sales of $1807.7 million in the United States.

With this approval, Zydus Lifesciences now holds 415 USFDA approvals, having filed 483 ANDAs since FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.

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