Source facts
FDA issued an approval letter for FAVLYXA on 2026-02-24. The source metadata identifies NDA 220201 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
FAVLYXA — FDA Approval Letter (NDA 220201)
Issued to AVYXA HOLDINGS. Application is approved as submitted.
Issued
February 24, 2026Application
NDA 505b1 • 220201
Product
FAVLYXA
Company
AVYXA HOLDINGS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for FAVLYXA?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 220201.
- 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 FAVLYXA approval letter
Is FAVLYXA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220201 for FAVLYXA, sponsored by AVYXA HOLDINGS, on February 24, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220201?
NDA 220201 is the application under which FDA issued this approval letter for FAVLYXA to AVYXA HOLDINGS. The letter is dated February 24, 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.