Issued to HORIZON THERAPEUTICS IRELAND. Application is approved as submitted.
Posted by FDA
September 25, 2026Application
BLA • 761143
Product
TEPEZZA
Company
HORIZON THERAPEUTICS IRELAND
Stage
Final Decision
Assyro regulatory brief
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FDA posted an approval letter for TEPEZZA on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761143 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved BLA 761143 for TEPEZZA, sponsored by HORIZON THERAPEUTICS IRELAND,. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
BLA 761143 is the application under which FDA issued this approval letter for TEPEZZA to HORIZON THERAPEUTICS IRELAND. FDA posted the letter on September 25, 2026; the posting date is not the decision date.
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.