Source facts
FDA issued an approval letter for XELJANZ on 2026-07-02. The source metadata identifies NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
XELJANZ — FDA Approval Letter (NDA 213082)
Issued to PFIZER. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for XELJANZ?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 213082.
- 3Submission: supplement.
- 4Sponsor: PFIZER.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the XELJANZ approval letter
Is XELJANZ FDA approved?
This letter documents an FDA approval action: FDA approved NDA 213082 for XELJANZ, sponsored by PFIZER, on July 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 213082?
NDA 213082 is the application under which FDA issued this approval letter for XELJANZ to PFIZER. The letter is dated July 2, 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.