FDA adds new AE data on label of Gilead's Truvada and Viread

The USA's Gilead Sciences says that the Food and Drug Administration has granted traditional approval status to its once-daily antiretroviral Viread (tenofovir disoproxil fumarate) and its fixed-dose product Truvada (emtricitabine and tenofovir disoproxil fumarate), which combines its two antiretrovirals Emtriva (emtricitabine) and Viread in a single daily tablet. Traditional approval means that US prescribing information for the agents now includes 48-week data from Study 934, a Phase III open-label trial comparing a once-daily regimen of Viread, Emtriva and efavirenz to twice-daily treatment with UK drug major GlaxoSmithKline's Combivir (lamivudine/zidovudine), which saw a higher number of discontinuations due to adverse events.