Zydus Cadila gets tentative nod from USFDA to market cancer drug

Drug firm Zydus Cadila on Wednesday said it has received tentative approval from the US health regulator to market Ibrutinib tablets used in the treatment of certain types of cancers. The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Ibrutinib tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg, Zydus Cadila said in a statement.

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, it added.

"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," Zydus Cadila said.


The group now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of its filing process, the company added.