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FDA NDA · NDA217225

IZERVAY

avacincaptad pegol

Sponsor: ASTELLAS

APPLICATION
NDA217225
TYPE
NDA
ORIGINAL APPROVAL
2023-08-04
LATEST ACTION
2026-02-27
ROUTE
INTRAVITREAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

IZERVAY · ReferencePrescription
AVACINCAPTAD PEGOL SODIUM EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML) · SOLUTION · INTRAVITREAL

Approval history

2026-02-27Labeling · Supplement 4 · standard — Label ↗AP
2025-02-12Efficacy · Supplement 1 · standard — Letter ↗AP
2023-08-04Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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