FDA approved the original biologics license application for ETICOVO on April 25, 2019, sponsored by SAMSUNG BIOEPIS CO LTD. FDA has approved 2 efficacy supplements on the application since, the most recent on May 3, 2024.
- Application
- BLA761066
- Sponsor
- SAMSUNG BIOEPIS CO LTD
- Original approval
- Review
- standard review
- Submission class
- Type 2 - New Active Ingredient
- Active ingredient
- etanercept-ykro
Browse every approval whose brand starts with E, 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 |
|---|---|---|---|
| etanercept-ykro 50MG/1ML | INJECTABLE | INJECTION | Prescription |
| etanercept-ykro 25MG/0.5ML | INJECTABLE | INJECTION | 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-3 | standard | |
| S-1 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 1. 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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