FDA approval · Drugs@FDA
ODEFSEYemtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate
NDA208351 ·
FDA approved the original new drug application for ODEFSEY on March 1, 2016, sponsored by GILEAD SCIENCES INC. FDA has approved 6 efficacy supplements on the application since, the most recent on February 19, 2025.
- Application
- NDA208351
- Sponsor
- GILEAD SCIENCES INC
- Original approval
- Review
- priority review
- Submission class
- Type 4 - New Combination
- Active ingredient
- emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate
Browse every approval whose brand starts with O, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| emtricitabine 200MG; rilpivirine hydrochloride EQ 25MG BASE; tenofovir alafenamide fumarate EQ 25MG BASE | TABLET | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-2 | standard | |
| S-3 | standard | |
| S-6 | standard | |
| S-10 | standard | |
| S-15 | standard | |
| S-14 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 3. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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