Mylotarg Purple Book BLA 761060

BLA number: 761060
Proprietary names: Mylotarg
Proper names: gemtuzumab ozogamicin
Applicant: Wyeth Pharmaceuticals LLC
Center: CDER
First observed release: 2020-05-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

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	Mylotarg	gemtuzumab ozogamicin	351(a)	4.5MG	For Injection	Intravenous	Single-Dose Vial	Rx	Licensed	2017-09-01

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.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
0008-4510	Mylotarg	gemtuzumab ozogamicin	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	current

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Mylotarg	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. \| Pharmacia & Upjohn Company LLC \| Wyeth Pharmaceutical Division of Wyeth Holdings LLC \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC	2025-12-19

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2022-04-01	U	001	Mylotarg	351(a)	Rx	Wyeth Pharmaceuticals LLC
2020-08-01	U	001	Mylotarg	351(a)	Rx	Wyeth Pharmaceuticals Inc.
2020-05-01	R	001	Mylotarg	351(a)	Rx	Wyeth Pharmaceuticals Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2020-05-01	001	Mylotarg	351(a)	Rx	Licensed	2017-09-01