Zydus Lifesciences subsidiary bags USFDA nod to market pulmonary arterial hypertension drug Selexipag

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.

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) to delay disease progression and reduce the risk of hospitalization for PAH.

The drug will be manufactured in the group's formulation manufacturing facility at Ahmedabad SEZ, India.

Selexipag tablet had annual sales of USD 577 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022). The group now has 338 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.

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Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus 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.

Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.