Zydus Cadila gets USFDA nod for cancer drug Ibrutinib
Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company has received tentative approval from the United States Food & Drug Administration (USFDA) to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg (US RLD: Imbruvica Tablets).
Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
The group now has 319 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.