Zydus Lifesciences gets USFDA nod for Pulmonary Arterial Hypertension drug Selexipag

Ahmedabad: 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.

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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 Cadila had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Macitentan Tablets, 10 mg (US RLD: Opsumit Tablets). Macitentan is used to manage the symptoms of pulmonary arterial hypertension. 

Read also: Zydus Macitentan Gets USFDA Okay, Eligible For 180 Days Of Shared Generic Drug Exclusivity

Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.