TMC278 is Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor for HIV-1 infection in adults.
Gilead previously submitted an NDA for the single-tablet regimen of Truvada/TMC278 on 23 November 2010.
The company had received a ‘refuse to file’ notification from the FDA regarding that submission on 25 January 2011.
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.