The product is expected to be launched in sub-Saharan Africa in late 2016
Aurobindo Pharma announced the tentative approval of Dolutegravir (DTG) 50mg from US Food and Drug Administration for the treatment of HIV. It is the first FDA approval of a generic version of DTG, an integrase strand transfer inhibitor recommended for use in treatment-naïve patients by the US Centres for Disease Control and Prevention and the WHO. Through an innovative collaboration with ViiV and the Clinton Health Access Initiative (CHAI), the product is expected to be launched in sub-Saharan Africa in late 2016.
The approved ANDA is bio-equivalent and therapeutically equivalent to the reference listed drug product Tivicay of ViiV Healthcare.
ViiV Healthcare, Aurobindo signed a licensing agreement in 2014 that allows Aurobindo Pharma to supply DTG 50mg in 92 licensed countries, following the completion of required local regulatory approval processes.