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FDA BLA · BLA761195

VYVGART

efgartigimod alfa

Sponsor: ARGENX BV

APPLICATION
BLA761195
TYPE
BLA
ORIGINAL APPROVAL
2021-12-17
LATEST ACTION
2026-05-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VYVGARTPrescription
EFGARTIGIMOD ALFA 400MG · INJECTABLE · INJECTION

Approval history

2026-05-08Efficacy · Supplement 16 · priority — Letter ↗AP
2025-10-17Efficacy · Supplement 12 · standard — Label ↗AP
2024-08-08Efficacy · Supplement 4 · standard — Letter ↗AP
2024-07-24Labeling · Supplement 6 · standard — Letter ↗AP
2023-12-12Labeling · Supplement 3 · standard — Letter ↗AP
2021-12-17Type 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.

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