Zydus receives USFDA tentative approval for Selexipag Tablets

10 May 2022 , 01:33 AM

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 1000 mcg 1200 mcg 1400 mcg and 1600 mcg USRLDUptravi 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