Global pharma major Lupin Limited announced that it has received tentative 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, to market a generic equivalent of Juluca® Tablets, 50 mg/25 mg of ViiV Healthcare Company.
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.
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).
