Aurobindo Pharma Limited announced that its wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets in multiple strengths — 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
The approved drug is the bioequivalent and therapeutic equivalent of Bristol-Myers Squibb’s Sprycel Tablets and is slated for launch in the first quarter of FY26. According to IQVIA MAT data for the twelve months ending February 2025, the market for Dasatinib Tablets in the U.S. is estimated to be worth approximately USD 1.8 billion.
This approval marks the 181st ANDA (Abbreviated New Drug Application) clearance — including nine tentative approvals — from Eugia Pharma Specialities Group's facilities, which focus on oncology and sterile specialty products.
Dasatinib is indicated for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in various stages, including newly diagnosed chronic phase, or in chronic, accelerated, or blast phase with resistance or intolerance to prior treatments such as imatinib. It is also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who have shown resistance or intolerance to earlier therapies.