Source facts
FDA issued an approval letter for OPUVIZ on 2026-03-23. The source metadata identifies BLA 761350 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
OPUVIZ — FDA Approval Letter (BLA 761350)
Issued to SAMSUNG BIOEPIS CO LTD. Application is approved as submitted.
Issued
March 23, 2026Application
BLA • 761350
Product
OPUVIZ
Company
SAMSUNG BIOEPIS CO LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for OPUVIZ?
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 761350.
- 3Submission: supplement.
- 4Sponsor: SAMSUNG BIOEPIS CO LTD.
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 OPUVIZ approval letter
Is OPUVIZ FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761350 for OPUVIZ, sponsored by SAMSUNG BIOEPIS CO LTD, on March 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761350?
BLA 761350 is the application under which FDA issued this approval letter for OPUVIZ to SAMSUNG BIOEPIS CO LTD. The letter is dated March 23, 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.