Drug firm Zydus Cadila said on Thursday that it had received final approval from the US health regulator for the marketing of Ibrutinib Capsules, which is used to treat certain cancers.
The company has also received approval to market the Macitentan tablet used to treat high blood pressure in the US market.
Cadila Healthcare said that Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) for the marketing of Ibrutinib Capsules with a strength of 70 mg and 140 mg.
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 stated that Ibrutinib capsules, 70 mg and Ibrutinib capsules, are eligible for 140 days of generic drug specificity for 140 mg.
The company said that 70 mg capsules have sales of US $ 32.5 million, while 140 mg supplements have sales of US $ 745.9 million.
Zydus Group managing director Sharvil Patel said the company is investing significantly in building a portfolio of complex generic products and leveraging capabilities, enabling it to gain meaningful market share in complex generic products and hard-to-manufacture products Will help
He added, “We have built a diversified portfolio of over 50 complex brief new drug applications (ANDAs) filed for USFDA approval and we will continue to expand this as we expand our US business in 2021 and beyond.” Seek opportunities, ”he said.
In a separate filing, Zydus Cadila stated that it had received final approval from the USFDA for the marketing of the MacFentan tablet, 10 mg.
Zydus Macitentan was one of the first ANDA applicants to submit a substantially complete ANDA with a Para IV certification for 10 mg, according to the USFDA letter. Therefore, with this approval, Zydus Macitentan tablets are eligible for 180 days of shared generic drug specificity for 10 mg.
The group now has 314 approvals and more than 400 ANDAs have been filed since the filing process began in FY 2003-04.
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