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Cadila gains on receiving final USFDA nod for Macitentan Tablets
08-Apr-21   09:18 Hrs IST

Macitentan is used to manage the symptoms of pulmonary arterial hypertension. Macitentan is in a class of medications called endothelin receptor antagonists. The drug 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.

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.

Meanwhile, Cadila also received final approval from the USFDA to market Ibrutinib Capsules. 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.

According to the USFDA letter, Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules. Therefore, with this approval, Zydus is eligible for 180 days of generic drug exclusivity for Ibrutinib Capsules. For Ibrutinib Capsules, 140 mg, the company will have 180-days of shared generic drug exclusivity. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

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.

Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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