RecallHawk

SARCLISA (ISATUXIMAB)

SANOFI AVENTIS US

Summary

FDA approved SARCLISA (ISATUXIMAB) by SANOFI AVENTIS US. BLA (Biologic) approval (Labeling) on 2026-06-26. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

BLA761113-18

Action Date

2026-06-26

Status

Approved

Category

drug

Product Code

BLA (Biologic)

Product Description

SARCLISA (generic: ISATUXIMAB), INJECTABLE, INJECTION. Application: BLA761113

Context & Analysis

SANOFI AVENTIS US has 14 FDA actions in our database.

Frequently Asked Questions

How often does SANOFI AVENTIS US have FDA actions?

SANOFI AVENTIS US has 14 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "BLA761113-18" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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