Zydus Lifesciences subsidiary Zydus Worldwide DMCC has received final approval from the U.S. Food and Drug Administration to market Selexipag Tablets in different strengths.
Indicated in adults for treatment of pulmonary arterial hypertension (PAH), the reference listed drug of the approved product is Uptravi tablets.
Since it was one of the first 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 it is eligible for 180 days of shared generic drug exclusivity, Zydus said.
The drug will be manufactured in the group’s formulation manufacturing facility at Ahmedabad SEZ. Selexipag tablet had annual sales of $577 million in the U.S., the company said citing IQVIA numbers.
