Aurobindo Pharma said it received tentative approval for its for anti-HIV drug Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate under the U.S. President’s Emergency Plan for AIDS Relief or PEPFAR.
The approved product is used for the treatment of HIV-1 infection along as a complete regimen in adults and pediatric patients weighing 40 kg and greater.
The triple combination product is expected to be launched in Sub-Saharan Africa in O3FY18, it said.
The drugs in the combination are ViV Healthcare’s Tivicay (dolutegravir) and Epivir (Lamivudine), and Gilead Science’s Vireado (Tenofovir Disoproxil Fumarate).
ViV 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.
Headquartered at Hyderabad, India, Aurobindo manufactures generic pharmaceuticals and active pharmaceutical ingredients.
The company’s manufacturing facilities are approved by Several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
It manufactures antibiotics, anti-Retrovirals, CVS, CNS, gastroenterologicals and other drugs.
PEPFAR uses US government funds to save HIV patients across the world. Through implementation of our strategy and use of data, PEPFAR is constantly innovating to generate greater efficiencies, drive down costs, and increase our impact, the organization claims.