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GSK: FDA Approves ViiV Healthcare's Dovato - Quick Facts

GlaxoSmithKline plc (GSK.L,GSK) reported that ViiV Healthcare announced the US FDA approved Dovato, a once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either DTG or 3TC.

DTG/3TC as a once-daily, single-tablet, two-drug regimen for HIV-1 therapy is currently under review by the European Medicines Agency and regulatory authorities in Canada, Australia, Switzerland, and South Africa and several additional submissions are planned throughout 2019.

ViiV Healthcare is a global specialist HIV company established in 2009 by GlaxoSmithKline and Pfizer.

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