Zydus Lifesciences arm gets USFDA tentative approval to market hypertension drug

Zydus Lifesciences on Friday said its subsidiary Zydus Worldwide DMCC has received tentative approval from the US health regulator to market its generic version of Selexipag tablets, used to treat pulmonary arterial hypertension in adults.

The approval by the US Food and Drug Administration (USFDA) is for 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 regulatory filing. These are the generic equivalent of the reference listed drug Uptravi.

It will be manufactured at the group's formulation facility at SEZ, Ahmedabad, the company said.

Selexipag is used in adults to treat pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalisation for PAH. Citing IQVIA MAT March 2022 data, the company said Uptravi tablets had annual sales of USD 551 million in the US.

The group now has 331 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in FY2003-04, Zydus said.