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FDA BLA · BLA761108

ULTOMIRIS

ravulizumab

Sponsor: ALEXION PHARM

APPLICATION
BLA761108
TYPE
BLA
ORIGINAL APPROVAL
2018-12-21
LATEST ACTION
2026-06-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ULTOMIRISPrescription
RAVULIZUMAB-CWVZ 300MG/30ML(10MG/ML) · INJECTABLE · INJECTION

Approval history

2026-06-01REMS · Supplement 45 — Letter ↗AP
2025-09-26Manufacturing (CMC) · Supplement 41 · standard — Label ↗AP
2025-06-27REMS · Supplement 40 — Letter ↗AP
2025-02-28REMS · Supplement 38 — Letter ↗AP
2024-09-19Labeling · Supplement 37 · standard — Label ↗AP
2024-06-28Labeling · Supplement 36 · standard — Label ↗AP
2024-03-22REMS · Supplement 31 — Letter ↗AP
2024-03-22Efficacy · Supplement 26 · standard — Letter ↗AP
2024-02-08Labeling · Supplement 35 · standard — Letter ↗AP
2022-07-22Efficacy · Supplement 21 · standard — Label ↗AP
2022-04-27Efficacy · Supplement 23 · priority — Label ↗AP
2022-01-07Labeling · Supplement 20 · standard — Label ↗AP
2021-11-22REMS · Supplement 24 — Letter ↗AP
2021-06-07Efficacy · Supplement 12 · priority — Letter ↗AP
2021-04-22Labeling · Supplement 15 · standard — Letter ↗AP
2020-10-09Efficacy · Supplement 5 · standard — Letter ↗AP
2020-04-30REMS · Supplement 7 — Letter ↗AP
2019-10-18Efficacy · Supplement 1 · priority — Label ↗AP
2018-12-21Type 1 - New Molecular Entity · Original · priority — 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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