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FOSTER CITY, Calif. — Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.
Gilead said it had resubmitted its application for a single-tablet combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Johnson & Johnson subsidiary Tibotec Pharmaceuticals’ investigational drug TMC278 (rilpivirine hydrochloride) to treat HIV-1 infection in adults.
Gilead had submitted its application for the drug in November 2010, but the FDA issued a “refuse to file” notification, requesting additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine.