Drug firm Zydus Cadila has said that the company has got the final approval from the US health regulator for marketing Ibrutinib Capsules used for treating certain cancers. It has also got received the nod to market Macitentan tablets, which are used for treating high blood pressure in the US market.
The company has got final approval from the US Food and Drug Administration (USFDA) for marketing Ibrutinib Capsules in 70 mg and 140 mg, it said in a regulatory filing.
Zydus Cadila has said it 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 $ 32.5 million, while the 140 mg dose has brand sales of $745.9 million, the company added.
Zydus Cadila, in a separate filing, has 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.