Source facts
FDA issued an approval letter for IBRANCE on 2026-06-26. The source metadata identifies NDA 207103 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
IBRANCE — FDA Approval Letter (NDA 207103)
Issued to PFIZER. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for IBRANCE?
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.
- 2Application: NDA 207103.
- 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 IBRANCE approval letter
Is IBRANCE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 207103 for IBRANCE, sponsored by PFIZER, on June 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 207103?
NDA 207103 is the application under which FDA issued this approval letter for IBRANCE to PFIZER. The letter is dated June 26, 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.