Zydus Gets USFDA Nod for Dasatinib Tablets

6 Mar 2025 , 03:27 PM

Zydus Lifesciences Ltd has bagged final approval from the US Food and Drug Administration (USFDA) to produce and market Dasatinib tablets in the US. The approved strengths are 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg.

Dasatinib is the generic version of Sprycel® tablets, a medication widely used for treating Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (Ph+ ALL). According to IQVIA MAT data (January 2025), Sprycel® tablets recorded annual sales of $1.81 billion in the US market.

The medication is primarily prescribed for:

• Newly diagnosed adults with Ph+ CML in the chronic phase.
• Patients with chronic, accelerated, or blast phase Ph+ CML who have shown resistance or intolerance to previous treatments.
• Adults with Ph+ ALL who have not responded well to prior therapies.

Dasatinib tablets will be manufactured at Zydus’ Ahmedabad SEZ facility. With this latest approval, Zydus has now secured a total of 415 regulatory approvals from the USFDA. However, the company has also submitted 483 ANDAs since the FY 03-04 (as of December 31, 2024).

Shares of Zydus Lifesciences Ltd is currently trading at ₹906.40 which is a 2.14% gain than the previous close, The stock has witnessed a total of 5.76% dip in the last one year, and 10% dip in the last one year.