Zydus Lifesciences subsidiary bags USFDA nod to market pulmonary arterial hypertension drug Selexipag
The drug will be manufactured in the group’s formulation manufacturing facility at Ahmedabad SEZ, India.;
Ahmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received final approval from the United States Food and Drug Administration (USFDA) to market Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg (USRLD: Uptravi tablets).
"Zydus Worldwide was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg and therefore is eligible for 180 days of shared generic drug exclusivity for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg," the company stated.
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