Tysabri launch date?

When did Tysabri (natalizumab) first launch?

Tysabri (natalizumab) was approved by the U.S. Food and Drug Administration (FDA) on November 15, 2004 and began its U.S. commercial availability after that approval [1].

What is the approval-to-market timeline for Tysabri?

The key date tied to “launch” in the U.S. is FDA approval on November 15, 2004 [1]. Any later “launch” dates you see in other markets depend on local regulatory approvals and rollout schedules, which can differ from the U.S. date.

Why do some sources show different “launch” dates?

If you see different dates, it’s usually because the source is mixing:
- Regulatory approval (FDA approval date is November 15, 2004) [1]
- First commercial shipment / first patient use after approval
- Launch in a specific country (which can come later)

If you tell me which country or what “launch” means on your site (FDA approval vs. first dosing vs. first commercial shipment), I can narrow it to the exact date.

Sources

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103950s516lbl.pdf