FDA approved the original biologics license application for TYSABRI on November 23, 2004, sponsored by BIOGEN IDEC. FDA classed that submission a new molecular entity, which makes it the first approval of natalizumab in any product. FDA has approved 5 efficacy supplements on the application since, the most recent on December 15, 2013.
- Application
- BLA125104
- Sponsor
- BIOGEN IDEC
- Original approval
- Review
- priority review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- natalizumab
Browse every approval whose brand starts with T, 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 |
|---|---|---|---|
| natalizumab 300MG | VIAL | SINGLE-USE | 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-15 | priority | |
| S-33 | standard | |
| S-67 | standard | |
| S-576 | standard | |
| S-840 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 26 · REMS 6 · Supplement 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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