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FDA BLA · BLA103950

KINERET

anakinra

Sponsor: BIOVITRUM AB

APPLICATION
BLA103950
TYPE
BLA
ORIGINAL APPROVAL
2001-11-14
LATEST ACTION
2025-10-27
ROUTE
SUBCUTANEOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

KINERETPrescription
ANAKINRA 25MIU/VIAL · VIAL · SUBCUTANEOUS
KINERETPrescription
ANAKINRA 10MIU/VIAL · VIAL · SUBCUTANEOUS
KINERETPrescription
ANAKINRA 18MIU/VIAL · VIAL · SUBCUTANEOUS

Approval history

2025-10-27Labeling · Supplement 5197 · standard — Label ↗AP
2024-09-19Labeling · Supplement 5198 · standard — Letter ↗AP
2020-12-18Efficacy · Supplement 5189 · priority — Label ↗AP
2020-02-02Supplement · Supplement 5183 · standardAP
2018-06-07Labeling · Supplement 5182 · standard — Label ↗AP
2016-11-16Labeling · Supplement 5177 · standardAP
2016-05-19Labeling · Supplement 5175 · standard — Letter ↗AP
2013-10-23Labeling · Supplement 5150 · standard — Label ↗AP
2012-12-21Efficacy · Supplement 5136 · priority — Letter ↗AP
2011-09-23Supplement · Supplement 5116 — Label ↗AP
2008-10-31Labeling · Supplement 5079 · standardAP
2006-12-15Efficacy · Supplement 5064 · standardAP
2006-02-22Efficacy · Supplement 5061 · standardAP
2005-08-09Labeling · Supplement 5058 · standardAP
2004-04-23Labeling · Supplement 5039 · standard — Label ↗AP
2003-08-22Efficacy · Supplement 5019 · standard — Letter ↗AP
2003-06-27Labeling · Supplement 5013 · standard — Label ↗AP
2001-11-14Type 1 - New Molecular Entity · Original · standard — Patient Package Insert ↗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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