Source facts
FDA issued an approval letter for SARCLISA ESCENA on 2026-07-13. The source metadata identifies BLA 761445 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SARCLISA ESCENA — FDA Approval Letter (BLA 761445)
Issued to SANOFI-AVENTIS U.S. LLC. Application is approved as submitted.
Issued
July 13, 2026Application
BLA • 761445
Product
SARCLISA ESCENA
Company
SANOFI-AVENTIS U.S. LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SARCLISA ESCENA?
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 761445.
- 3Submission: original application.
- 4Sponsor: SANOFI-AVENTIS U.S. LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SARCLISA ESCENA approval letter
Is SARCLISA ESCENA FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761445 for SARCLISA ESCENA, sponsored by SANOFI-AVENTIS U.S. LLC, on July 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 761445?
BLA 761445 is the application under which FDA issued this approval letter for SARCLISA ESCENA to SANOFI-AVENTIS U.S. LLC. The letter is dated July 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.