First FDA filing of generic dolutegravir for the treatment of HIV

26 May 2015

ViiV Healthcare, Aurobindo Pharma (BSE: 524804) and the Clinton Health Access Initiative Inc (CHAI) announced today that Aurobindo Pharma has submitted an Abbreviated New Drug Application for dolutegravir 50mg to the Food and Drug Administration for the treatment of HIV.

This is the first ANDA submitted to the FDA for a generic version of dolutegravir, and comes less than two years after US FDA approval of Tivicay (dolutegravir), from ViiV Healthcare, a GlaxoSmithKline (LSE: GSK) joint venture partnered with Pfizer (NYSE: PFE) and Japan’s Shionogi (TYO: 4507).

Upon receiving tentative approval, Aurobindo will be able to manufacture and supply dolutegravir 50mg in 121 least developed, low income and sub-Saharan Africa countries, on an affordable yet sustainable basis.

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