Zydus Cadila announces final USFDA approval for Macitentan Tablets, 10 mg and gets eligibility for 180-day shared exclusivity

Zydus Cadila has received final approval from the USFDA to market Macitentan Tablets, 10 mg (US RLD: Opsumit Tablets). Macitentan is used to manage the symptoms of pulmonary arterial hypertension. Macitentan 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.

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.

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.

Shares of CADILA HEALTHCARE LTD. was last trading in BSE at Rs.461.25 as compared to the previous close of Rs. 456.8. The total number of shares traded during the day was 269845 in over 5797 trades.

The stock hit an intraday high of Rs. 464.5 and intraday low of 454.15. The net turnover during the day was Rs. 124280346.

Source : Equity Bulls

Keywords