Lupin gains USFDA approval for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension
The fixed-dose combination is indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg
Lupin has received tentative approval from the United States Food and Drug Administration (US 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 will 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.
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