Aurobindo Pharma arm gets USFDA nod for leukemia drug; share price jumps over 4.5%

The drug major’s subsidiary Eugia Pharma Specialities has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

This is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), the company further said.

Following the approval, shares of Aurobindo Pharma surged 4.77% to ₹1,244.40 apiece on the National Stock Exchange.

The product is expected to be launched in Q1 FY26. The approved product has an estimated market size of US$ 1.8 billion for the twelve months ending February 2025, according to IQVIA MAT.

Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase (ii) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib (iii) adults with Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy.

“This is the 181st ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile speciality products,” the company said in a statement to the stock exchanges.

Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

The company has 30+ manufacturing and packaging facilities that are approved by leading regulatory agencies, including the US FDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.