Lupin gets USFDA tentative nod for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension for HIV-1 infection
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) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) 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 and will be supplied to low-and middle-income countries.
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.
Ramesh Swaminathan, Executive Director, Global CFO & Head of API Plus SBU, Lupin stated, “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.”
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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.
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