Drug firm Zydus Cadila on Thursday said it has received final approval from the US health regulator to market Ibrutinib Capsules, used to treat certain cancers. The company has also received nod to market Macitentan tablets, used to treat high blood pressure, in the American market.
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Ibrutinib Capsules in the strengths of 70 mg and 140 mg, Cadila Healthcare said in a regulatory filing.
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 company said is eligible for 180 days of generic drug exclusivity for Ibrutinib Capsules, 70 mg and for Ibrutinib Capsules, 140 mg.
The 70 mg capsule has brand sales of USD 32.5 million, while the 140 mg dose has brand sales of USD 745.9 million, the company added.