FDA approve new NNRTI-based fixed dose combination of rilpivirine/tenofovir/FTC (Complera) in the US
On 10 August 2011, US Food and Drug Administration (FDA) approved a fixed-dose combination of rilpivirine/tenofovir/FTC (Complera) with an indication in treatment-naive adults. This is a single-tablet once-daily combination.
Approval was based on bioequivilence to the individual drugs taken separately, together with the phase 3 registrational studies for rilpivirine (ECHO and THRIVE) – see FDA approve rilpivirine in the US.
US Food and Drug Administration approves Gilead sciences Complera, a new complete once-daily, single-tablet regimen for HIV-1 infection in treatment-naive adults. Gilead press release. (10 August 2011).