Source facts
FDA issued an approval letter for KALYDECO on 2026-03-19. The source metadata identifies NDA 203188, NDA 207925 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
KALYDECO — FDA Approval Letter (NDA 203188)
Issued to VERTEX PHARMS. Application is approved as submitted.
Issued
March 19, 2026Application
NDA 505b1 • 203188
Product
KALYDECO
Company
VERTEX PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for KALYDECO?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 203188, NDA 207925.
- 3Submission: supplement.
- 4Sponsor: VERTEX PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the KALYDECO approval letter
Is KALYDECO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 203188 for KALYDECO, sponsored by VERTEX PHARMS, on March 19, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 203188?
NDA 203188 is the application under which FDA issued this approval letter for KALYDECO to VERTEX PHARMS. The letter is dated March 19, 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.