Zydus Lifesciences Gets USFDA’s Tentative Nod For Generic Ibrutinib Tablets Used In Blood Cancer
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.

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. | X @stockwatch_live
New Delhi: 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 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.
(Except for the headline, this article has not been edited by FPJ's editorial team and is auto-generated from an agency feed.)
RECENT STORIES
-
Mumbai News: Residents Oppose BMC’s ₹300–500 Crore Alternate Tank Plan For Malabar Hill... -
MP News: CS Anurag Jain Unaware Of Ground Reality On Land Issues, Says ACS Deepali Rastogi -
Bhopal News: Teachers Protest TET, Set April 11 Deadline For Government Action -
Mumbai News: ₹58 Crore SIES Fraud Case Stalled As Missing FIR Delays Trial, Court Issues Fresh... -
MP News: AI-Powered System To Feature Criminal Profiling, Predictive Policing And 20-language...
