Aurobindo Pharma Secures USFDA Nod for Dasatinib Tablets

Aurobindo Pharma's subsidiary, Eugia Pharma Specialities Ltd, received USFDA approval for its generic Dasatinib tablets, used in treating certain bone marrow and blood cancers. The approval covers multiple dosages and the product is set to launch in Q1FY26, tapping into a market valued at $1.8 billion.

Aurobindo Pharma's wholly-owned subsidiary, Eugia Pharma Specialities Ltd, has successfully obtained final approval from the US Food and Drug Administration (USFDA) to manufacture and market a generic equivalent of Dasatinib tablets. This drug is crucial in treating specific types of bone marrow and blood cancers.

The regulatory nod includes the production and marketing of Dasatinib tablets in various strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These tablets are bioequivalent and therapeutically comparable to the reference Sprycel Tablets, originally developed by Bristol-Myers Squibb Company (BMS).

With plans to launch in the first quarter of FY26, the product is expected to make a significant impact within a rapidly growing market, estimated at $1.8 billion as of February 2025, according to IQVIA MAT data.

(With inputs from agencies.)