Zydus Lifesciences receives tentative approval from USFDA for Chronic lymphocytic leukaemia drug Ibrutinib

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-07-24T15:24:04+05:30 | Updated On 24 July 2025 3:24 PM IST

Ahmedabad: Zydus Lifesciences Limited has announced that it 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 USD 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.

Read also: Zydus Asked to Revise Phase III Trial Protocol for Cough Syrup FDC After CDSCO Panel Review

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.

zydus lifescienceszydus lifesciences newsUSFDAIbrutinib tabletsImbruvica tabletslymphocytic leukaemiawaldenstroms macroglobulinemia

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751