Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) under the US 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 paediatric 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 US FDA for our abacavir, dolutegravir and lamivudine tablets enables us to improve the well-being of paediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.
