← FDA DRUG APPROVALS

FDA BLA · BLA761113

SARCLISA

isatuximab

Sponsor: SANOFI AVENTIS US

APPLICATION
BLA761113
TYPE
BLA
ORIGINAL APPROVAL
2020-03-02
LATEST ACTION
2026-06-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SARCLISAPrescription
ISATUXIMAB-IRFC 500MG/25ML (20MG/ML) · INJECTABLE · INJECTION
SARCLISAPrescription
ISATUXIMAB-IRFC 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION

Approval history

2026-06-26Labeling · Supplement 18 · standard — Letter ↗AP
2024-10-25Efficacy · Supplement 11 · standard — Label ↗AP
2024-10-25Efficacy · Supplement 12 · standard — Label ↗AP
2024-09-20Efficacy · Supplement 14 · priority — Label ↗AP
2023-11-01Efficacy · Supplement 9 · standard — Label ↗AP
2022-07-15Labeling · Supplement 6 · standard — Letter ↗AP
2021-03-31Efficacy · Supplement 3 · standard — Label ↗AP
2021-03-18Labeling · Supplement 4 · standard — Label ↗AP
2020-03-02Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →