Zydus Cadilla gets US FDA clearance for generic ibrutinib, macitentan

Zydus Cadilla gets US FDA clearance for generic ibrutinib, macitentan

Zydus Cadila has received USFDA approval for marketing its generic ibrutinib capsules. The drug is available in 70 mg and 140 mg.

Ibrutinib is a kinase inhibitor and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma, and Waldenstrom’s macroglobulinemia. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad.

The company has also recently received nod from the USFDA to market macitentan tablets, 10 mg. Macitentan is used to manage the symptoms of pulmonary arterial hypertension.

Macitentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have pulmonary arterial hypertension.