← FDA DRUG APPROVALS

FDA BLA · BLA125147

VECTIBIX

panitumumab

Sponsor: AMGEN

APPLICATION
BLA125147
TYPE
BLA
ORIGINAL APPROVAL
2006-09-27
LATEST ACTION
2025-01-16
ROUTE
INTRAVENOUS, IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VECTIBIXPrescription
PANITUMUMAB 20ML/400MG · INJECTABLE · IV (INFUSION)
VECTIBIXPrescription
PANITUMUMAB 5ML/100MG · INJECTABLE · IV (INFUSION)
VECTIBIXPrescription
PANITUMUMAB 10ML/200MG · INJECTABLE · IV (INFUSION)

Approval history

2025-01-16Efficacy · Supplement 213 · priority — Label ↗AP
2021-08-25Labeling · Supplement 210 · standard — Letter ↗AP
2017-06-29Efficacy · Supplement 207 · standard — Label ↗AP
2015-03-11Labeling · Supplement 200 · standard — Letter ↗AP
2014-08-30Labeling · Supplement 194 · standard — Label ↗AP
2014-05-23Efficacy · Supplement 186 · standard — Label ↗AP
2014-05-23Efficacy · Supplement 108 · standard — Label ↗AP
2013-03-28Labeling · Supplement 169 · standard — Label ↗AP
2012-08-17Labeling · Supplement 148 · standard — Label ↗AP
2012-08-17Labeling · Supplement 152 · standard — Letter ↗AP
2011-12-12Labeling · Supplement 137 · standardAP
2011-03-15Labeling · Supplement 123 · standardAP
2010-05-26Labeling · Supplement 103 · standardAP
2009-07-17Labeling · Supplement 78 · standardAP
2009-07-17Labeling · Supplement 80 · standard — Label ↗AP
2009-04-27Labeling · Supplement 67 · standard — Label ↗AP
2008-06-23Efficacy · Supplement 26 · standard — Letter ↗AP
2007-11-06Labeling · Supplement 18 · standard — Label ↗AP
2006-09-27Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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