New Delhi: Aurobindo Pharma has received tentative approval from the USFDA for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, used for the treatment of HIV, in the US market.
In a BSE filing, Aurobindo Pharma said it has received “tentative approval from the US Food and 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 tablets.
The approval has been granted in strength of 50mg/ 300mg/ 300mg.
Aurobindo Pharma said the triple combination product is expected to be launched in sub-Saharan Africa in the third quarter of this fiscal.
The reference listed drugs of the approved combination products are ViiV Healthcare’s Tivicay and Epivir and Gilead Science’s Viread, it added.
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.