Source facts
FDA issued an approval letter for CYSVIEW KIT on 2026-06-23. The source metadata identifies NDA 022555 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CYSVIEW KIT — FDA Approval Letter (NDA 022555)
Issued to PHOTOCURE ASA. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 022555
Product
CYSVIEW KIT
Company
PHOTOCURE ASA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CYSVIEW KIT?
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 022555.
- 3Submission: supplement.
- 4Sponsor: PHOTOCURE ASA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CYSVIEW KIT approval letter
Is CYSVIEW KIT FDA approved?
This letter documents an FDA approval action: FDA approved NDA 022555 for CYSVIEW KIT, sponsored by PHOTOCURE ASA, on June 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 022555?
NDA 022555 is the application under which FDA issued this approval letter for CYSVIEW KIT to PHOTOCURE ASA. The letter is dated June 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.