Source facts
FDA issued a tentative approval letter for EDARAVONE on 2026-07-21. The source metadata identifies NDA 221059 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
EDARAVONE — FDA Tentative Approval Letter (NDA 221059)
Issued to AZURITY PHARMACEUTICALS INC. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
July 21, 2026Application
NDA 505b1 • 221059
Product
EDARAVONE
Company
AZURITY PHARMACEUTICALS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for EDARAVONE?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: tentative approval.
- 2Application: NDA 221059.
- 3Submission: original application.
- 4Sponsor: AZURITY PHARMACEUTICALS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the EDARAVONE tentative approval letter
Is EDARAVONE FDA approved?
Not for marketing yet. FDA granted tentative approval to NDA 221059 for EDARAVONE on July 21, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
What is NDA 221059?
NDA 221059 is the application under which FDA issued this tentative approval letter for EDARAVONE to AZURITY PHARMACEUTICALS INC. The letter is dated July 21, 2026.
What happens after an FDA tentative approval letter?
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.