Aurobindo Pharma Limited announced that its subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These tablets are bioequivalent and therapeutically equivalent to Sprycel Tablets, the reference drug developed by Bristol-Myers Squibb Company (BMS). The product is set to launch in the first quarter of FY26.

The approved Dasatinib Tablets have an estimated market size of $1.8 billion for the twelve months ending February 2025, as per IQVIA MAT data. This marks the 181st ANDA approval, including nine tentative approvals, from Eugia Pharma Specialities Group (EPSG), which specializes in manufacturing oncology oral and sterile specialty products.

Dasatinib is indicated for treating various conditions, including newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. It is also prescribed for adults with chronic, accelerated, or blast phase Ph+ CML who show resistance or intolerance to prior therapies, including imatinib.

Additionally, it is used for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to previous treatments.