Lupin receives USFDA’s approval for Selexipag for Injection

02 Nov 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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. This product will be manufactured at Lupin’s Nagpur facility in India.

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

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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