5 days ago
Zydus Lifesciences gets tentative approval from USFDA for Ibrutinib tablets
Zydus Lifesciences has received tentative approval from the USFDA to market Ibrutinib tablets in the 140 mg, 280 mg, and 420 mg strengths in the U.S. market. The drug is a generic version of Imbruvica® and is used in treating adult patients with Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p deletion, as well as Waldenstrom's Macroglobulinemia (WM).
The tablets will be manufactured at Zydus' SEZ facility in Ahmedabad. According to IQVIA (MAT May 2025), Ibrutinib tablets clocked annual sales of USD 2.15 billion in the U.S.
With this, Zydus now holds 420 approvals and has filed 484 ANDAs since it began filings in FY 2003-04.
In the meantime, Zydus Lifesciences shares opened today at ₹962.95 and, at the time of writing, touched a high of ₹976.60 during the session. The stock also hit a low of ₹960.15 in intraday trade. Over the past year, Zydus shares have seen a 52-week high of ₹1,324.30 and a low of ₹795.00.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
