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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