Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg (USRLD: Imbruvica tablets, 140 mg, 280 mg and 420 mg).

Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion, and Waldenstrom's macroglobulinemia (WM).

Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Ibrutinib tablets had annual sales of US$ 2148.9 mn in the United States (IQVIA MAT May 2025).

The group now has 420 approvals and has so far filed 484 ANDAs since the commencement of the filing process in FY 2003-04.