India, July 24 -- Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has received tentative approval from the U.S. Food and Drug Administration (USFDA) for Ibrutinib tablets in 140 mg, 280 mg, and 420 mg strengths. These tablets are the generic equivalents of Imbruvica® tablets, indicated for the treatment of adult patients with Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion, and Waldenstrom's Macroglobulinemia (WM).
The approved products will be manufactured at Zydus Lifesciences' SEZ facility in Ahmedabad. According to IQVIA MAT data for May 2025, Ibrutinib tablets generated annual sales of approximately USD 2.15 billion in the U.S. market.
With this latest approval, Zydus...