Source facts
FDA issued an approval letter for BAXFENDY on 2026-06-15. The source metadata identifies NDA 219878 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
BAXFENDY — FDA Approval Letter (NDA 219878)
Issued to ASTRAZENECA AB. Application is approved as submitted.
Issued
June 15, 2026Application
NDA 505b1 • 219878
Product
BAXFENDY
Company
ASTRAZENECA AB
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for BAXFENDY?
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 219878.
- 3Submission: original application.
- 4Sponsor: ASTRAZENECA AB.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the BAXFENDY approval letter
Is BAXFENDY FDA approved?
This letter documents an FDA approval action: FDA approved NDA 219878 for BAXFENDY, sponsored by ASTRAZENECA AB, on June 15, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 219878?
NDA 219878 is the application under which FDA issued this approval letter for BAXFENDY to ASTRAZENECA AB. The letter is dated June 15, 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.