FDA gives Lupin tentative OK for generic Triumeq PD
Lupin has gained tentative approval from the Food and Drug Administration for abacavir, dolutegravir and lamivudine tablets for oral suspension, 60 mg/5 mg/30 mg, which is a generic of ViiV Healthcare’s Triumeq PD tablets for Oral Suspension.
The product will be manufactured at Lupin’s Nagpur facility in India.
[Read more: Lupin receives FDA OK for generic Banzel]
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 a market value of roughly $1.3 million, per IQVIA September 2024 data.
[Read more: FDA gives Lupin tentative nod for generic Janumet]