TEPEZZA (TEPROTUMUMAB)
Summary
FDA approved TEPEZZA (TEPROTUMUMAB) by HORIZON THERAPEUTICS IRELAND. BLA (Biologic) approval (Labeling) on 2025-11-24. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA761143-32
Action Date
2025-11-24
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
TEPEZZA (generic: TEPROTUMUMAB), INJECTABLE, INJECTION. Application: BLA761143
Company
Context & Analysis
Frequently Asked Questions
How often does HORIZON THERAPEUTICS IRELAND have FDA actions?
This is the only FDA action we have on record for HORIZON THERAPEUTICS IRELAND in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA761143-32" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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