Aurobindo Pharma's Eugia unit gains USFDA nod for dasatinib

Aurobindo Pharma Limited (BSE:AUROPHARMA) announced today that its wholly-owned subsidiary, Eugia Pharma Specialities Limited, secured final approval from the U.S. Food & Drug Administration (USFDA) for its Dasatinib Tablets. This approval covers multiple strengths (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg) of the generic drug, which is bioequivalent to Bristol-Myers Squibb's Sprycel. The launch is expected in Q1FY26. Dasatinib Tablets are indicated for the treatment of certain types of leukemia. According to IQVIA MAT, the approved product addresses a significant market, estimated at USD 1.8 billion for the twelve months ending February 2025. The approval marks the 181st ANDA approval for Eugia Pharma Specialities Group.