Aurobindo Pharma has received tentative approval from the USFDA to manufacture and market Dolutegravir, used for the treatment of HIV, in the US market.
In a BSE filing, Aurobindo Pharma said it has received “tentative approval for Dolutegravir 50 mg from US Food & Drug Administration (USFDA) for the treatment of HIV.
“Through an innovative collaboration with ViiV and the Clinton Health Access Initiative, Inc. (CHAI), the product is expected to be launched in sub-Saharan Africa in late 2016.”
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Tivicay, of ViiV Healthcare, 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.
Dolutegravir 50mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
“This important milestone marks the first FDA approval of a generic version of Dolutegravir (DTG), an integrase strand transfer inhibitor recommended for use in treatment-naïve patients by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO),” it said.
Stock of Aurobindo Pharma was trading 4.07 per cent higher at Rs 839 on BSE.