Aurobindo Pharma’s wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dasatinib Tablets, available in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg strengths.
Dasatinib Tablets are the generic equivalent of Bristol-Myers Squibb’s Sprycel Tablets and are indicated for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML) in adults and children, and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) in adults. The company plans to launch the product in the first quarter of FY26.
According to IQVIA data, the approved product has an estimated market size of around $1.8 billion (approximately ₹15,000 crore) in the US for the 12-month period ending February 2025.
This approval marks the 181st ANDA (Abbreviated New Drug Application), including nine tentative approvals, from Eugia Pharma Specialities Group, which is focused on oncology, critical care, and other specialty therapeutic segments.
Meanwhile, Aurobindo Pharma shares rose 1.5% intraday following the announcement.
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