Zydus Lifesciences 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).
Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase. It is also used to treat adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib and adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.
Dasatinib tablets had annual sales of USD 1807.7mn in the United States (IQVIA MAT January 2025).