USFDA gives Lupin a provisional approval for a BP medication; shares up 4%

 USFDA gives Lupin a provisional approval for a BP medication; shares up 4%

With this permission, Lupin may now sell a generic version of Actelion Pharmaceuticals US, Inc.'s original Uptravi for Injection, which has a dosage of 1800 mcg per vial.

The US Food and Drug Administration (FDA) has tentatively approved Lupin Limited's Abbreviated New Drug Application for Selexipag injectable.

With this permission, the Mumbai-based company would be able to sell a generic version of Uptravi, which was manufactured by Actelion Pharmaceuticals US, Inc. and contains 1800 mcg per vial. According to the business, the generic medicine would be produced at Lupin's Nagpur plant.

In order to prevent symptoms from becoming worse, selenipag is used to treat pulmonary arterial hypertension, or high blood pressure in the blood arteries that supply the lungs.

In the United States, revenues from the Selexipag franchise were $1,104 million for the year that ended December 31, 2022, and $978 million for the nine months that ended October 1, 2023.

The Indian pharmaceutical company also reported receiving an Establishment Inspection Report (EIR) for its Madhya Pradesh-based Mandideep Unit-2 production plant from the US health authorities.

The plant was given the inspection rating "No Action Indicated" after the inspection concluded.

Lupin was up 3.94 percent from the previous close as of 1:39 PM on the National Stock Exchange, trading at Rs 1,177.35.

On November 8, Lupin—which employs over 20,000 people worldwide and has 15 production locations, seven research facilities, and a large workforce—will release its September quarter financial results.