Abacavir hydroxyacetate

Mumbai: Generics drug maker Lupin Limited announced that it has received tentative approval from the FDA under the US President’s Emergency Plan for AIDS Relief for its Abacavir, Dolutegravir and Lamivudine tablets for oral suspension. 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. This product would be manufactured at the company's Nagpur facility in India and will be supplied to low-and middle-income countries, the release stated. Ramesh Swaminathan, Executive Director, Global CFO & Head -API Plus SBU, Lupin said, “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the U.S. FDA for our Abacavir, Dolutegravir and Lamivudine Tablets enables us to improve the well-being of pediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.” The generic version is equivalent to Triumeq PD Tablets for Oral Suspension, of ViiV Healthcare Company owned by GSK, with Pfizer and Shionogi as minority shareholders around 15 per cent and 5 per cent respectively. As of September 2024, Triumeq has an annual sales of $1.3 million in the US drug market and the novel drug had pediatric exclusivity till December 2026. By Online Bureau ,

Lupin has been granted tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application 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. 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 US. Lupin 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. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the US 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, along with a dedicated workforce of over 22,000 professionals.