Global pharma major Lupin Limited on Thursday announced that it 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.
According to the company’s statement, the approval has been granted 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 the 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.
