The dolutegravir new drug application earlier submitted to the US agency included results from four pivotal phase III trials conducted in a total of 2553 HIV/AIDS patients.
ViiV Healthcare, established by GlaxoSmithKline and Pfizer, has also previously submitted dolutegravir marketing authorisation application to the European Medicines Agency.
Dolutegravir, an integrase inhibitor, is also known as S/GSK1349572 or just 572.