Key facts
| Sponsor | SANOFI-AVENTIS U.S. LLC |
|---|---|
| Brand name | SARCLISA ESCENA |
| Generic name | unspecified |
| Dosage form | VIAL |
| Application number | BLA761445 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
What was approved
FDA's record shows SANOFI-AVENTIS U.S. LLC as the sponsor of SARCLISA ESCENA, with the generic name recorded as unspecified and dosage form VIAL. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. This specific application is submission type ORIG (submission number 1) under application number BLA761445, with a submission status date of 20260709. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.
Regulatory context
This application was reviewed under FDA's ORIG submission pathway. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.
SANOFI-AVENTIS U.S. LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to SANOFI-AVENTIS U.S. LLC: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.
Frequently asked questions
- Does SANOFI-AVENTIS U.S. LLC have other FDA approval records?
- This is the only FDA action Argus HQ has on file for SANOFI-AVENTIS U.S. LLC so far. Argus ingests new FDA records daily.
- What is the FDA application number for this submission?
- FDA application number BLA761445, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: STANDARD.
- What dosage form is SARCLISA ESCENA?
- SARCLISA ESCENA is formulated as: VIAL.
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Related enforcement actions
Full FDA history for SANOFI-AVENTIS U.S. LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). SARCLISA ESCENA (SANOFI-AVENTIS U.S. LLC): FDA ORIG Approval, Not disclosed in the FDA record.. Digital Empire LLC. Retrieved from https://argushq.ai/approval/sanofi-aventis-u-s-bla761445-2026-07-09
"SARCLISA ESCENA (SANOFI-AVENTIS U.S. LLC): FDA ORIG Approval, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/sanofi-aventis-u-s-bla761445-2026-07-09.
Argus HQ Research. "SARCLISA ESCENA (SANOFI-AVENTIS U.S. LLC): FDA ORIG Approval, Not disclosed in the FDA record.." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/approval/sanofi-aventis-u-s-bla761445-2026-07-09.
@misc{argushq_argushq_ai_approval_sanofi_aventis_u_s_bla761445_2026_07_09_2026,
title = {SARCLISA ESCENA (SANOFI-AVENTIS U.S. LLC): FDA ORIG Approval, Not disclosed in the FDA record.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/approval/sanofi-aventis-u-s-bla761445-2026-07-09},
note = {Accessed: July 15, 2026}
}Source: FDA.gov — Approvals ↗