Gilead Sciences, Inc. received a “refuse to file” notification from the FDA regarding Gilead’s NDA for the single-tablet regimen of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. The FDA requested additional information with respect to the Chemistry, Manufacturing and Controls (CMC) section of the Truvada/TMC278 NDA submission...