Lupin bags USFDA nod for Dolutegravir, Rilpivirine tablets to treat HIV infection

Mumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, to market a generic equivalent of Juluca Tablets, 50 mg/25 mg of ViiV Healthcare Company.

Dolutegravir and Rilpivirine are antiretroviral medications to treat HIV/AIDS infection.

Human immunodeficiency virus (HIV) is an infection that attacks the body’s immune system, specifically the white blood cells called CD4 cells. HIV destroys these CD4 cells, weakening a person’s immunity against opportunistic infections, such as tuberculosis and fungal infections, severe bacterial infections and some cancers.

Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of USD 666 million in the U.S. (IQVIA MAT September 2022).

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22. 

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