Source facts
FDA issued an approval letter for YUVEZZI on 2026-01-29. The source metadata identifies NDA 220142 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
YUVEZZI — FDA Approval Letter (NDA 220142)
Issued to VISUS. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for YUVEZZI?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 220142.
- 3Submission: original application.
- 4Sponsor: VISUS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the YUVEZZI approval letter
Is YUVEZZI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220142 for YUVEZZI, sponsored by VISUS, on January 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220142?
NDA 220142 is the application under which FDA issued this approval letter for YUVEZZI to VISUS. The letter is dated January 29, 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.