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FDA tentatively OKs Mylan's HIV combo pill

Feb. 20, 2018 11:38 AM ETViatris Inc. (VTRS) StockBy: Douglas W. House, SA News Editor13 Comments
  • The FDA has tentatively approved Mylan N.V.'s (MYL -1.4%) fixed-dose combination of dolutegravir, emtricitabine and tenofovir alafenamide for the treatment of HIV infection in developing countries.
  • Dolutegravir is the active ingredient in ViiV Healthcare's TIVICAY. Emtricitabine and alafenamide are the active ingredients in Gilead Sciences' (GILD +0.9%) DESCOVY.
  • Tentative approval means that Mylan's marketing application met the criteria for approval but patent issues need to be resolved.
  • Related tickers: (GSK -0.2%)(PFE +0.3%)(OTCPK:SGIOY -0.1%).

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