FDA tentatively OKs Zydus Cadila’s generic Imbruvica

Zydus Cadila has received tentative approval from the Food and Drug Administration for Ibrutinib tablets, in dosage strengths of 140 mg, 280 mg, 420 mg and 560 mg.

The product is the generic of Imbruvica.

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.