Zydus Lifesciences Ltd announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its generic version of Ibrutinib tablets, used in the treatment of various blood cancers.
The approval covers 140 mg, 280 mg, and 420 mg tablet strengths, and the product will be manufactured at the company’s SEZ facility in Ahmedabad, the company said in a statement.
Ibrutinib is indicated for use in adult patients with several types of blood cancers, including:
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Waldenström's Macroglobulinemia (WM)
The tentative approval brings Zydus one step closer to expanding its oncology portfolio in the U.S. market, providing more affordable treatment options for patients living with hematological malignancies.