- 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%).