SARCLISA ESCENA (isatuximab-irfc) · SANOFI-AVENTIS U.S. LLC
SARCLISA ESCENA is FDA-approved to treat 1 condition (same as SARCLISA).
Details
- Status
- Prescription
- First Approved
- 2026-07-09
- Routes
- SINGLE-DOSE
- Dosage Forms
- VIAL
SARCLISA ESCENA Approval History
What SARCLISA ESCENA Treats
1 indicationsSARCLISA ESCENA is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as SARCLISA (same active ingredient).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SARCLISA ESCENA FDA Label Details
Indications & Usage
SARCLISA ESCENA is FDA-approved to treat 1 condition — same approved indications as SARCLISA.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.