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# Odefsey Labeling Changes Approved
- URL: https://www.fdaweb.com/odefsey-labeling-changes-approved/
- Published: 2017-08-22T12:00:00.000Z
- Updated: 2026-09-14T22:42:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139441

FDA says it approved 8/21 changes to labeling for Guilead’s Odefsey (emtricitabine/rilpivirine/tenofovir/alafenamide HIV-1 treatment. The changes add data from 48-week trials in which subjects switched to Odefsey from tenofovir disoproxil fumarate-based regimens such as Gilead’s Complera or Bristol-Myers Squibb’s Atripla. The Adverse Reactions section of the label was updated in areas covering clinical trials experience, microbiology, and clinical trial results.