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FDA BLA · BLA125388

ADCETRIS

brentuximab vedotin

Sponsor: SEATTLE GENETICS

APPLICATION
BLA125388
TYPE
BLA
ORIGINAL APPROVAL
2011-08-19
LATEST ACTION
2025-02-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ADCETRISPrescription
BRENTUXIMAB VEDOTIN 50MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-02-11Efficacy · Supplement 108 · standard — Label ↗AP
2023-06-23Manufacturing (CMC) · Supplement 104 — Letter ↗AP
2023-06-14Efficacy · Supplement 107 · standard — Letter ↗AP
2022-11-10Efficacy · Supplement 106 · priority — Label ↗AP
2019-10-15Labeling · Supplement 100 · standard — Letter ↗AP
2018-11-16Efficacy · Supplement 99 · priority — Label ↗AP
2018-03-20Efficacy · Supplement 97 · priority — Label ↗AP
2017-11-09Efficacy · Supplement 94 · priority — Label ↗AP
2016-09-28Labeling · Supplement 88 · standard — Letter ↗AP
2016-03-04Labeling · Supplement 84 · standard — Label ↗AP
2015-08-17Labeling · Supplement 81 · standard — Label ↗AP
2015-08-17Efficacy · Supplement 80 · priority — Label ↗AP
2014-11-23Labeling · Supplement 78 · standard — Letter ↗AP
2014-11-23Labeling · Supplement 56 · standard — Label ↗AP
2013-08-19Labeling · Supplement 45 · standard — Label ↗AP
2012-01-13Labeling · Supplement 5 · standard — Label ↗AP
2012-01-13Labeling · Supplement 11 · standardAP
2011-08-19Efficacy · Supplement 6 · priorityAP
2011-08-19Type 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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