Source facts
FDA issued an approval letter for DARZALEX FASPRO on 2026-02-13. The source metadata identifies BLA 761145 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DARZALEX FASPRO — FDA Approval Letter (BLA 761145)
Issued to JANSSEN BIOTECH. Application is approved as submitted.
Issued
February 13, 2026Application
BLA • 761145
Product
DARZALEX FASPRO
Company
JANSSEN BIOTECH
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DARZALEX FASPRO?
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: BLA 761145.
- 3Submission: supplement.
- 4Sponsor: JANSSEN BIOTECH.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the DARZALEX FASPRO approval letter
Is DARZALEX FASPRO FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761145 for DARZALEX FASPRO, sponsored by JANSSEN BIOTECH, on February 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761145?
BLA 761145 is the application under which FDA issued this approval letter for DARZALEX FASPRO to JANSSEN BIOTECH. The letter is dated February 13, 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.