← FDA DRUG APPROVALS

FDA BLA · BLA761150

MARGENZA

margetuximab-cmkb

Sponsor: MACROGENICS INC

APPLICATION
BLA761150
TYPE
BLA
ORIGINAL APPROVAL
2020-12-16
LATEST ACTION
2025-01-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MARGENZAPrescription
MARGETUXIMAB-CMKB 250MG/10ML(25MG/ML) · INJECTABLE · INJECTION

Approval history

2025-01-15Labeling · Supplement 11 · standard — Letter ↗AP
2023-05-25Efficacy · Supplement 5 · standard — Letter ↗AP
2020-12-16Type 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 →