The Food and Drug Administration granted tentative approval to AuroBindo Pharma for dolutegravir, a drug intended to treat patients with HIV, reported Business Standard.
Dolutegravir is the generic equivalent to ViiV Healthcare's drug Tivcay.
India-based Aurobindo Pharma entered a licensing agreement with Viiv Healthcare in 2014 that allows the drugmaker to license dolutegravir in 92 countries, pending the drug's approval from local regulatory agencies.
Aurobindo Pharma will launch the drug in Africa in late 2016 as part of a collaboration with Viiv Healthcare and the Clinton Health Access Initiative[AC2], which seeks to provide HIV treatments to people in developing countries.