Zydus Cadila receives tentative approval from USFDA for Ibrutinib

Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg, the company said in a statement.

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, it added.

It also said that the drug will be manufactured at the group’s formulation manufacturing facility at the Special Economic Zone (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,” the statement also notified.