Wednesday 21 April 2021
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business-standard - 13 days ago

Zydus Cadila receives USFDA approval for Macitentan Tablets

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.


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