← FDA DRUG APPROVALS

FDA NDA · NDA216834

ZILBRYSQ

zilucoplan

Sponsor: UCB INC

APPLICATION
NDA216834
TYPE
NDA
ORIGINAL APPROVAL
2023-10-17
LATEST ACTION
2026-01-22
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ZILBRYSQ · ReferencePrescription
ZILUCOPLAN SODIUM EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) · SOLUTION · SUBCUTANEOUS
ZILBRYSQ · ReferencePrescription
ZILUCOPLAN SODIUM EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) · SOLUTION · SUBCUTANEOUS
ZILBRYSQ · ReferencePrescription
ZILUCOPLAN SODIUM EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-01-22Labeling · Supplement 13 · standard — Letter ↗AP
2025-02-28REMS · Supplement 9 — Label ↗AP
2025-02-28Labeling · Supplement 8 · standard — Label ↗AP
2024-04-26Labeling · Supplement 1 · standard — Label ↗AP
2024-01-16REMS · Supplement 4 — Letter ↗AP
2023-10-17Type 1 - New Molecular Entity · Original · standard — Label ↗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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