Zydus Lifesciences gets tentative nod from USFDA for generic blood cancer drug

Zydus Lifesciences Ltd on Thursday said it has received tentative approval from the US health regulatory agency for its generic version of cancer treatment drug Ibrutinib tablets.

The tentative approval granted by the US Food and Drug Administration (USFDA) is for Ibrutinib tablets of strengths 140 mg, 280 mg, and 420 mg, Zydus Lifesciences said in a statement.

The Ibrutinib tablets will be produced at Zydus Lifesciences Ltd SEZ, Ahmedabad, it added.


The company said Ibrutinib is indicated for the treatment of adult patients with different types of blood cancers, Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL), and Waldenstrom's macroglobulinemia (WM).

Citing IQVIA MAT May 2025, Zydus said Ibrutinib tablets had annual sales of USD 2148.9 million in the US.