Source facts
FDA issued an approval letter for EPYSQLI on 2026-01-26. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
EPYSQLI — FDA Approval Letter (BLA 761340)
Issued to SAMSUNG BIOEPIS CO LTD. Application is approved as submitted.
Issued
January 26, 2026Application
BLA • 761340
Product
EPYSQLI
Company
SAMSUNG BIOEPIS CO LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for EPYSQLI?
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 761340.
- 3Submission: supplement.
- 4Sponsor: SAMSUNG BIOEPIS CO LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the EPYSQLI approval letter
Is EPYSQLI FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761340 for EPYSQLI, sponsored by SAMSUNG BIOEPIS CO LTD, on January 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761340?
BLA 761340 is the application under which FDA issued this approval letter for EPYSQLI to SAMSUNG BIOEPIS CO LTD. The letter is dated January 26, 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.