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FDA BLA · BLA125319

ILARIS

canakinumab

Sponsor: NOVARTIS PHARMS

APPLICATION
BLA125319
TYPE
BLA
ORIGINAL APPROVAL
2009-06-17
LATEST ACTION
2024-11-01
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ILARISPrescription
CANAKINUMAB 180MG · INJECTABLE · SUBCUTANEOUS

Approval history

2024-11-01Labeling · Supplement 110 · standard — Letter ↗AP
2023-08-25Efficacy · Supplement 107 · standard — Letter ↗AP
2020-09-18Labeling · Supplement 100 · standard — Letter ↗AP
2020-06-16Efficacy · Supplement 97 · priority — Letter ↗AP
2016-12-22Manufacturing (CMC) · Supplement 88 · standard — Label ↗AP
2016-09-23Efficacy · Supplement 85 · priority — Label ↗AP
2016-09-23Efficacy · Supplement 86 · priority — Label ↗AP
2016-09-23Efficacy · Supplement 87 · priority — Label ↗AP
2016-07-21Efficacy · Supplement 84 · standard — Label ↗AP
2014-10-16Labeling · Supplement 81 · standard — Label ↗AP
2013-05-09Efficacy · Supplement 62 · priority — Label ↗AP
2012-10-11Labeling · Supplement 54 · standard — Label ↗AP
2012-03-30Labeling · Supplement 47 · standard — Label ↗AP
2011-11-17Labeling · Supplement 14 · standardAP
2009-06-17Type 1 - New Molecular Entity · Original · priority — Review ↗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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