Zydus Receives Tentative Approval For Selexipag Tablets From USFDA

Mumbai, May 6: Pharma major Zydus Lifesciences a subsidiary of Zydus Worldwide DMCC said it 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.

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).