Lupin secures tentative USFDA nod for Selexipag for Injection

Mumbai: Global pharma major Lupin Limited today announced that the Company has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Selexipag for Injection, 1800 mcg/vial, Single-Dose Vial, to market a generic equivalent of Uptravi for Injection, 1800 mcg/vial, of Actelion Pharmaceuticals US, Inc.

Selexipag is used for the treatment of pulmonary arterial hypertension to slow down the worsening of symptoms.

This product will be manufactured at Lupin’s Nagpur facility in India.

The product sales for Selexipag Franchise (RLD Uptravi) in U.S. were USD 1,104 million for the year ended December 2022 and USD 978 million for the fiscal nine months ended October 1, 2023.

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.

The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

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