Zydus Lifesciences receives tentative USFDA approval for Selexipag Tablets

6 May 2022 , 04:10 PM

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.

Zydus Lifesciences ended at Rs338 apiece down by Rs2.4 or 0.71% on the BSE.