Zydus Cadila has acquired last approval from the USFDA to market Macitentan Tablets, 10 mg (US RLD: Opsumit Tablets). Macitentan is used to handle the signs of pulmonary arterial hypertension. Macitentan is in a category of medicines known as endothelin receptor antagonists. It really works by stopping the motion of endothelin, a pure substance that causes blood vessels to slender and prevents regular blood stream in individuals who have Pulmonary Arterial Hypertension.
In line with the USFDA letter, Zydus was one of many first ANDA candidates to submit a considerably full ANDA with a paragraph IV certification for Macitentan Tablets, 10 mg. Due to this fact, 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 to this point filed over 400 ANDAs for the reason that graduation of the submitting course of in FY 2003-04.