Aurobindo Pharma receives USFDA tentative approval for Dolutegravir

22 Sep 2016 Evaluate

Aurobindo Pharma has received tentative approval for Dolutegravir 50mg from US Food & Drug Administration (USFDA). 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-naive patients by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). 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 Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tivicay, of ViiV Healthcare. 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. The approval of the generic version of DTG shows the commitment towards the larger cause of bringing affordable HIV drugs to millions of people. This is a one-of-its-kind agreement between innovator and generic company where the generic version of the drug will be launched in around three years from the originator product.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments

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