Source facts
FDA issued an approval letter for XELJANZ, XELJANZ XR on 2026-03-09. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
XELJANZ / XELJANZ XR — FDA Approval Letter (NDA 203214)
Issued to PF PRISM CV. Application is approved as submitted.
Issued
March 9, 2026Application
NDA 505b1 • 203214
Product
XELJANZ / XELJANZ XR
Company
PF PRISM CV
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for XELJANZ / XELJANZ XR?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 203214, NDA 208246, NDA 213082.
- 3Submission: supplement.
- 4Sponsor: PF PRISM CV.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the XELJANZ / XELJANZ XR approval letter
Is XELJANZ / XELJANZ XR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 203214 for XELJANZ / XELJANZ XR, sponsored by PF PRISM CV, on March 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 203214?
NDA 203214 is the application under which FDA issued this approval letter for XELJANZ / XELJANZ XR to PF PRISM CV. The letter is dated March 9, 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.