Aurobindo Pharma’s subsidiary, Eugia Pharma Specialities, has received final approval from the US Food and Drug Administration (FDA) to manufacture and market Dasatinib Tablets in various strengths. The approved product is bioequivalent and therapeutically equivalent to Bristol-Myers Squibb Company’s (BMS) Sprycel Tablets. Dasatinib Tablets are used to treat certain types of leukemia, including Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia.
The approval is significant, as the estimated market size for the product is $1.8 billion for the twelve months ending February 2025, according to IQVIA MAT numbers. The company plans to launch the product by June. This is the 181st Abbreviated New Drug Application (ANDA) approval received by Eugia Pharma Specialities Group (EPSG) facilities, which manufacture both oncology oral and sterile specialty products.
Dasatinib Tablets are indicated for the treatment of newly diagnosed adults with Ph+ chronic myeloid leukemia in chronic phase, as well as adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy. The product is also used to treat adults with Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
The approval demonstrates Aurobindo Pharma’s commitment to expanding its product portfolio and increasing its presence in the global pharmaceutical market. The company’s subsidiary, Eugia Pharma Specialities, has a strong track record of receiving FDA approvals, with 181 ANDA approvals to date. The launch of Dasatinib Tablets is expected to contribute to the company’s revenue growth and help it achieve its business objectives.
Overall, the FDA approval of Dasatinib Tablets is a significant milestone for Aurobindo Pharma and its subsidiary, Eugia Pharma Specialities. The product has the potential to make a significant impact in the treatment of certain types of leukemia, and the company is well-positioned to capitalize on the growing demand for affordable and effective pharmaceuticals.