Adcetris Purple Book BLA 125399

This BLA is retained from the historical Purple Book archive and was not present in the newest imported release. FDA.report does not infer a regulatory status from that absence.

BLA number: 125399
Proprietary names: Adcetris
Proper names: brentuximab vedotin
Applicant: Seattle Genetics, Inc.
Center: CDER
First observed release: 2020-05-01
Latest observed release: 2021-02-01
Newest archive release: 2021-02-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Historical archive only

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Adcetris	brentuximab vedotin	351(a)	50MG	For injection	Intravenous	Single-Dose Vial	Rx	Licensed	2011-08-19

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2020-08-01	U	001	Adcetris	351(a)	Rx	Seattle Genetics, Inc.
2020-05-01	R	001	Adcetris	351(a)	Rx	Seattle Genetics, Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2020-05-01	001	Adcetris	351(a)	Rx	Licensed	2011-08-19