Zydus Cadila receives FDA blessing for generic Opsumit

Zydus Cadila has received the Food and Drug Administration’s nod for Macitentan tablets, in a dosage strength of 10 mg.

The product is the generic of Opsumit.

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

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, Zydus is eligible for 180 days of shared generic drug exclusivity for the drug.