Triumeq PD (dolutegravir/abacavir/lamivudine oral suspension) / ViiV Healthcare - LARVOL DELTA

Lupin Receives Approval from U.S. FDA for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension (Lupin Pharmaceuticals Press Release) - "Global pharma major Lupin Limited (Lupin) today 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."

ANDA • Human Immunodeficiency Virus

Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV (PRNewswire) - "Viatris Inc...announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients. The World Health Organization (WHO) recommends abacavir/dolutegravir/lamivudine as a preferred first-line regimen for paediatric patients."

NDA • Human Immunodeficiency Virus • Infectious Disease