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FDA BLA · BLA125249

ARCALYST

rilonacept

Sponsor: KINIKSA PHARMACEUTICALS (UK), LTD.

APPLICATION
BLA125249
TYPE
BLA
ORIGINAL APPROVAL
2008-02-27
LATEST ACTION
2026-03-10
ROUTE
SUBCUTANEOUS, SINGLE-USE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ARCALYSTPrescription
RILONACEPT 220MG · VIAL · SINGLE-USE

Approval history

2026-03-10Labeling · Supplement 57 · standard — Label ↗AP
2021-03-18Efficacy · Supplement 49 · priority — Label ↗AP
2020-12-18Efficacy · Supplement 47 · priority — Label ↗AP
2020-02-12Labeling · Supplement 45 · standard — Label ↗AP
2010-09-30Labeling · Supplement 18 · standardAP
2008-02-27Type 1 - New Molecular Entity · Original · priority — 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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