By: IPP Bureau
Last updated : November 04, 2023 11:20 am
This product will be manufactured at Lupin's Nagpur facility in India
Global pharma major Lupin Limited (Lupin) announced that it 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. This product will be manufactured at Lupin's Nagpur facility in India.
The product sales for Selexipag Franchise (RLD Uptravi) in U.S. were US$ 1,104 million for the year ended December 2022 and US$ 978 million for the fiscal nine months ended October 1, 2023.