Source facts
FDA issued an approval letter for VFEND on 2026-02-23. The source metadata identifies NDA 021266, NDA 021267, NDA 021630 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
VFEND — FDA Approval Letter (NDA 021266)
Issued to PF PRISM CV. Application is approved as submitted.
Issued
February 23, 2026Application
NDA 505b1 • 021266
Product
VFEND
Company
PF PRISM CV
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for VFEND?
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.
- 2Applications: NDA 021266, NDA 021267, NDA 021630.
- 3Submission: supplement.
- 4Sponsor: PF PRISM CV.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the VFEND approval letter
Is VFEND FDA approved?
This letter documents an FDA approval action: FDA approved NDA 021266 for VFEND, sponsored by PF PRISM CV, on February 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 021266?
NDA 021266 is the application under which FDA issued this approval letter for VFEND to PF PRISM CV. The letter is dated February 23, 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.