Gilead Sciences, Inc. announced that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. Gilead previously submitted an NDA for the single-tablet regimen of Truvada/TMC278 on November 23, 2010. The company announced on January 25, 2011 that it had received a “refuse to file” notification from the FDA regarding that submission.
Specifically, the FDA requested additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine; this information has been included in the refiling.
The FDA has up to 60 days to conduct a preliminary review to assess whether the NDA is sufficiently complete to permit a substantive review. The FDA will establish a target action date for the NDA, under the Prescription Drug User Fee Act (PDUFA), if the application is formally filed.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.