Zydus Lifesciences has reached an important milestone by receiving approval from the United States Food and Drug Administration (USFDA) to sell its generic version of Dasatinib tablets in the US market. This medicine is used for treating a type of blood cancer known as chronic myeloid leukemia (CML) and another condition called acute lymphoblastic leukemia (ALL). With this approval, the company strengthens its position in the global pharmaceutical market.
Dasatinib is a widely used medicine for patients diagnosed with Philadelphia chromosome-positive (Ph+) CML in the chronic phase. It is also used for those in more advanced stages of the disease or who have not responded well to previous treatments. The original version of the drug, sold under the brand name Sprycel, had annual sales of $1.81 billion in the US as of January 2025. By launching a generic version, Zydus aims to provide a more affordable alternative to patients in need.
The newly approved drug will be available in multiple strengths, including 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. This allows doctors to prescribe doses tailored to individual patient needs. Zydus will manufacture the tablets at its facility in Ahmedabad’s SEZ, ensuring high-quality production while keeping costs competitive.
This approval adds to Zydus’ growing list of regulatory clearances. Since the financial year 2003-04, the company has filed 483 applications for drug approvals in the US, out of which 415 have been successfully approved. This steady progress highlights Zydus’ commitment to expanding its portfolio of medicines in the global market.