Lupin bags USFDA tentative approval for Dolutegravir and Rilpivirine Tablets

16 Jan 2023 , 01:46 AM

Lupin Limited (Lupin) today announced that it has received preliminary approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, and for a generic version of Juluca Tablets, 50 mg/25 mg.

In the United States, Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg (RLD Juluca) had an estimated annual sales of USD 666 million (IQVIA MAT September 2022).

Lupin is a transnational pharmaceutical company based in Mumbai, India that focuses on innovation. The company develops and commercializes a diverse range of branded and generic formulations, biotechnology products, and APIs in over 100 markets worldwide, including the United States, India, South Africa, Latin America (LATAM), and Asia Pacific (APAC), Europe, and the Middle East.

At around 1.43 PM, Lupin was trading at Rs752.85, down by 0.38% against the previous close of Rs755.75 on NSE. The counter touched an intraday high and low of Rs760 and Rs747.15 respectively.

For feedback and suggestions, write to us at [e-mail]