Aurobindo Pharma Gets USFDA Nod for Leukemia Drug Dasatinib

23 Apr 2025 , 01:24 PM

Aurobindo Pharma made an announcement stating that its fully-owned subsidiary, Eugia Pharma Specialities Limited, has got final USFDA approval to make and sell Dasatinib Tablets in the US.

Following the news, shares of Aurobindo Pharma has raised, trading at an 4.14% gain. The stock has gained a total of 13% in the last one year, and 2% in the last one month.

Dasatinib Tablets are used for treating leukaemia in adults and children, including:

• Adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase.
• Adult patients with Ph+ CML in chronic, accelerated, or blast phase (myeloid or lymphoid) who are refractory or intolerant to previous therapy, including Imatinib.
• Adult patients with Ph+ acute lymphoblastic leukaemia (ALL) who have manifested resistance or intolerance to prior treatment.

Dasatinib Tablets US market size was approximately $1.8 billion for the 12 months ended February 2025, based on industry data. Aurobindo Pharma is going to launch Dasatinib in Q1 FY26, which will be in line with its plans to enhance its oncology portfolio in the US generics market.

Earlier this April, Aurobindo had also received USFDA approval for the manufacture and marketing of Rivaroxaban Tablets USP, 2.5mg, a generic equivalent of Xarelto 2.5mg of Janssen Pharmaceuticals. The company is going to launch Rivaroxaban Tablets in the first quarter of FY26, yet another addition to its portfolio in the anticoagulant space.