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Aurobindo Pharma Ltd has received tentative approval from the US Food & Drug Administration (USFDA) under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its new drug application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) tablets.
The approved product is used for the treatment of HIV-1 infection as a complete regimen in adults and paediatric patients weighing 40 kg and greater.
The reference listed drugs of the approved combination product are ViiV Healthcare’s Tivicay (Dolutegravir) and Epivir (Lamivudine), and Gilead Science’s Viread (Tenofovir Disoproxil Fumarate), the company said in a release issued here on Monday.
ViiV Healthcare and Aurobindo Pharma signed a licensing agreement in 2014 that allows Aurobindo Pharma to supply Dolutegravir 50mg in 92 licensed countries, following completion of required local regulatory approval processes.
The triple combination product is expected to be launched in sub-Saharan Africa in Q3FY18.
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