← FDA DRUG APPROVALS

FDA BLA · BLA761458

EXDENSUR

depemokimab

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
BLA761458
TYPE
BLA
ORIGINAL APPROVAL
2025-12-16
LATEST ACTION
2026-06-10
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTION
MARKETING STATUS
Prescription

Products

EXDENSURPrescription
DEPEMOKIMAB-ULAA 100MG · INJECTION

Approval history

2026-06-10Labeling · Supplement 2 · standardLetterAP
2025-12-16Type 1 - New Molecular Entity · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industryGMP disciplineFDA drug shortagesFDA 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 →