Drug firm Zydus Cadila on Thursday said it has received final approval from the U.S. 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 U.S. 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.
Zydus Group Managing Director Sharvil Patel said the company has been investing significantly in building a portfolio of complex generic products and leveraging capabilities that will help it successfully commercialise and gain meaningful market share in the complex generic products and difficult-to-manufacture generic products.
"We have created a diversified portfolio of over 50 filed complex abbreviated new drug applications (ANDAs) seeking USFDA approval and we will continue to expand this as we explore opportunities to grow our U.S. business in 2021 and beyond,” he said.
In a separate filing, Zydus Cadila said it has received final approval from the USFDA to market Macitentan tablets, 10 mg.
According to the USFDA letter, Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Macitentan Tablets, 10 mg. Therefore, with this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Macitentan Tablets, 10 mg.
The group now has 314 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
