Zydus receives tentative approval from US FDA for Selexipag tablets

Zydus Lifesciences’s subsidiary Zydus Worldwide DMCC has received tentative approval from the US Food and Drug Administration (FDA) 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, the company said in a statement.

Selexipag is used in adults to treat Pulmonary Arterial Hypertension (PAH) to delay disease progression and reduce the risk of hospitalisation for PAH. It is a prostacyclin receptor agonist. The drug will be manufactured at group’s formulation facility at SEZ, Ahmedabad, the statement added.