Source facts
FDA issued an approval letter for ORKAMBI on 2026-03-19. The source metadata identifies NDA 206038, NDA 211358 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ORKAMBI — FDA Approval Letter (NDA 206038)
Issued to VERTEX PHARMS INC. Application is approved as submitted.
Issued
March 19, 2026Application
NDA 505b1 • 206038
Product
ORKAMBI
Company
VERTEX PHARMS INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ORKAMBI?
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 206038, NDA 211358.
- 3Submission: supplement.
- 4Sponsor: VERTEX PHARMS INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ORKAMBI approval letter
Is ORKAMBI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 206038 for ORKAMBI, sponsored by VERTEX PHARMS INC, 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 206038?
NDA 206038 is the application under which FDA issued this approval letter for ORKAMBI to VERTEX PHARMS INC. 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.