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

July/August 2011

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..


References

  1. U.S. 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).
  2. Prescribing information.

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