Lupin bags tentative USFDA okay for Abacavir, Dolutegravir, Lamivudine Tablets for Oral Suspension for HIV treatment
Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, to market a generic equivalent of Triumeq PD Tablets for Oral Suspension, of ViiV Healthcare Company.
This product would be manufactured at Lupin’s Nagpur facility in India.
The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg.
HIV-1 (Human Immunodeficiency Virus Type 1) is a virus that attacks the immune system, specifically targeting CD4+ T cells, which are crucial in defending the body against infections. HIV-1 is the most common and widespread strain of the virus that causes HIV infection and, if untreated, can progress to AIDS (Acquired Immunodeficiency Syndrome).
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, (RLD Triumeq PD) had an estimated annual sale of USD 1.3 million in the U.S. (IQVIA MAT September 2024).
Medical Dialogues team had earlier reported that the Company had received tentative approval from the USFDA for its ANDA for Raltegravir Tablets USP, 600 mg, to market a generic equivalent of Isentress HD Tablets, 600 mg of Merck Sharp & Dohme LLC.
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Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
