Source facts
FDA issued an approval letter for JAKAFI XR on 2026-05-04. The source metadata identifies NDA 217180 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
JAKAFI XR — FDA Approval Letter (NDA 217180)
Issued to INCYTE CORP. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for JAKAFI XR?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 217180.
- 3Submission: original application.
- 4Sponsor: INCYTE CORP.
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Common questions about the JAKAFI XR approval letter
Is JAKAFI XR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 217180 for JAKAFI XR, sponsored by INCYTE CORP, on May 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 217180?
NDA 217180 is the application under which FDA issued this approval letter for JAKAFI XR to INCYTE CORP. The letter is dated May 4, 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.