FDA Approve New NNRTI-Based Fixed-Dose Combination of Rilpivirine/Tenofovir/FTC (Complera) in the U.S.
On 10 August 2011, U.S. 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 U.S..
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