Zydus Lifesciences Limited has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture Dasatinib Tablets in multiple strengths—20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. This approval allows Zydus to offer a high-quality, cost-effective alternative to Sprycel® Tablets in the U.S. market.
Dasatinib is a key medication for treating Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in newly diagnosed adults. It is also prescribed for adults with chronic, accelerated, or blast phase Ph+ CML who have developed resistance or intolerance to prior therapies, including imatinib. Additionally, it is used for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults who cannot tolerate previous treatments.
Zydus will manufacture Dasatinib Tablets at its state-of-the-art facility in Ahmedabad, India. With annual sales of $1.8 billion in the U.S. (IQVIA MAT, January 2025), the launch of Dasatinib is expected to strengthen Zydus’ presence in the U.S. generics market.
This latest approval marks a significant milestone for Zydus, which now boasts 415 USFDA approvals and has filed 483 ANDAs since 2003-04. The company continues to expand its portfolio, reinforcing its commitment to providing affordable, high-quality medicines worldwide.
