Mumbai, April 23 -- The drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets by Bristol-Myers Squibb Company (BMS).

Dasatinib is approved for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults and children, including newly diagnosed cases. It is also indicated for Ph+ CML with resistance or intolerance to prior therapies like imatinib and for Ph+ acute lymphoblastic leukemia (ALL) with treatment resistance or intolerance.

The approved product has an estimated market size of US$ 1.8 billion for the twelve months ending February 2025, according to IQVIA MAT. This marks the 181st ANDA approval (including 9 tentative approvals) from Eugia Pharma Specialt...