UNITUXIN (DINUTUXIMAB)
Summary
FDA approved UNITUXIN (DINUTUXIMAB) by UNITED THERAP. BLA (Biologic) approval (Labeling) on 2025-10-10. INJECTABLE, INTRAVENOUS.
Details
Source
Drug Approval
External ID
BLA125516-41
Action Date
2025-10-10
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
UNITUXIN (generic: DINUTUXIMAB), INJECTABLE, INTRAVENOUS. Application: BLA125516
Company
Context & Analysis
UNITED THERAP has 3 FDA actions in our database.
Frequently Asked Questions
How often does UNITED THERAP have FDA actions?
UNITED THERAP has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA125516-41" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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