Zydus receives tentative approval from USFDA for Selexipag Tablets

Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Selexipag Tablets in the strengths of 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg (USRLD: Uptravi®). Selexipag is used in adults to treat pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization for PAH. Selexipag is a prostacyclin receptor agonist. The drug will be manufactured at group's formulation facility at SEZ, Ahmedabad.

Uptravi® (Selexipag) Tablets had annual sales of USD 551mn in the United States (as per IQVIA MAT Mar-22 data).

The group now has 331 approvals and has so far filed over 400 ANDAs since the commencement of filing process in FY 2003-04.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 340.40 as compared to the previous close of Rs. 339.20. The total number of shares traded during the day was 64641 in over 2011 trades.

The stock hit an intraday high of Rs. 346.95 and intraday low of 338.20. The net turnover during the day was Rs. 22170758.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 TentativeApproval USFDA SelexipagTablets