FDA Updates Complera Labeling with New Indication and Clinical Trial Information

“On January 25, 2013, FDA approved changes to the Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) package insert. The major changes include restricting the indication to treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL, updating the package insert with the 96 week results from the Phase 3 trials and adding a new Contraindication and new Warning and Precaution for hepatotoxicity.” More information is available: FDA: Press release FDA: Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) label (PDF)