Source facts
FDA issued an approval letter for AVOPEF on 2026-02-18. The source metadata identifies NDA 220200 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
AVOPEF — FDA Approval Letter (NDA 220200)
Issued to AVYXA HOLDINGS. Application is approved as submitted.
Issued
February 18, 2026Application
NDA 505b1 • 220200
Product
AVOPEF
Company
AVYXA HOLDINGS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for AVOPEF?
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: approval.
- 2Application: NDA 220200.
- 3Submission: original application.
- 4Sponsor: AVYXA HOLDINGS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the AVOPEF approval letter
Is AVOPEF FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220200 for AVOPEF, sponsored by AVYXA HOLDINGS, on February 18, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220200?
NDA 220200 is the application under which FDA issued this approval letter for AVOPEF to AVYXA HOLDINGS. The letter is dated February 18, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.