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This Article is From Nov 02, 2023

Lupin Gets U.S. FDA Nod To Market Generic Medication

Lupin gets USFDA nod to market generic medication

Lupin Gets U.S. FDA Nod To Market Generic Medication
(source: Lupin Website) 

Drug maker Lupin on Thursday said it has received approval from the U.S. health regulator to market generic medication to treat pulmonary arterial hypertension.

It has received tentative approval from the US Food and Drug Administration (USFDA) for Selexipag for injection, Lupin said in a regulatory filing.

The company's product is a generic version of Actelion Pharmaceuticals U.S., Inc.'s  Uptravi for injection.

Lupin said the product would be manufactured at its Nagpur facility.

The product sales for Selexipag franchise in the U.S. stood at $1,104 million for the year ended December 2022.

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