23-04-2025
Aurobindo Pharma receives USFDA approval for Dasatinib Tablets; Stock jumps
By Aditya Bhagchandani Published on April 23, 2025, 11:26 IST
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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Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
