DARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT))
Summary
FDA approved DARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)) by JANSSEN BIOTECH. BLA (Biologic) approval (Labeling) on 2026-02-12. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA761145-39
Action Date
2026-02-12
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
DARZALEX FASPRO (generic: DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)), INJECTABLE, INJECTION. Application: BLA761145
Company
Context & Analysis
JANSSEN BIOTECH has 5 FDA actions in our database.
Frequently Asked Questions
How often does JANSSEN BIOTECH have FDA actions?
JANSSEN BIOTECH has 5 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 "BLA761145-39" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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