Lupin Gets USFDA Approval for Generic Pulmonary Hypertension Drug
Lupin receives USFDA approval to market generic Selexipag for injection, a treatment for pulmonary arterial hypertension. The drug will be manufactured at the company's Nagpur facility.
New Delhi, Nov 2 (PTI) Drug maker Lupin on Thursday said it has received approval from the US 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 US, Inc.'s Uptravi for injection.
Lupin said the product would be manufactured at its Nagpur facility.
The product sales for Selexipag franchise in the US stood at USD 1,104 million for the year ended December 2022.
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 US, Inc.'s Uptravi for injection.
Lupin said the product would be manufactured at its Nagpur facility.
The product sales for Selexipag franchise in the US stood at USD 1,104 million for the year ended December 2022.
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