approval · primary record
ISATUXIMAB-IRFC
2 approval events · latest 2026-07-09
| Agency | FDA |
|---|---|
| Submission type | BLA |
| Latest action | 2026-07-09 |
| Approval events | 2 |
| Brand | SARCLISA ESCENA |
| Sponsor | SANOFI-AVENTIS U.S. LLC |
| Route | SINGLE-DOSE |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-07-09 | FDA | BLA | SARCLISA ESCENA | SANOFI-AVENTIS U.S. LLC | SINGLE-DOSE |
| 2026-06-26 | FDA | BLA | SARCLISA | SANOFI AVENTIS US | INJECTION |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:30:53.724Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:isatuximab-irfc
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Isatuximab-Irfc · compound