Zydus receives USFDA tentative approval for Selexipag Tablets

6 May 2022 , 01:04 PM

Zydus Lifesciences 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 groups 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). Powered by Capital Market – Live News