Lupin gets USFDA nod for generic HIV drug
Lupin on Friday said it has received approval from the US health regulator to market a generic HIV medication in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for Abacavir, Dolutegravir and Lamivudine tablets, the Mumbai-base drug maker said in a statement.
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The company's product is a generic equivalent of ViiV Healthcare Company's Triumeq PD tablets for oral suspension, it added.
This product would be manufactured at the drug firm's Nagpur facility and will be supplied to low-and middle-income countries, it said.
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.
«The tentative approval from the USFDA 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,» Lupin Executive Director, Global CFO & Head of API Plus SBU Ramesh Swaminathan said.
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