FDA.reportPublic FDA data

Besponsa Purple Book BLA 761040

BLA number
761040
Proprietary names
Besponsa
Proper names
inotuzumab ozogamicin
Applicant
Wyeth Pharmaceuticals LLC
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-10-01
Newest archive release
2026-10-01
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
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Besponsainotuzumab ozogamicin351(a)0.9MGFor InjectionIntravenousSingle-Dose VialRxLicensed2017-08-17

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
ReleaseEventProductNameLicense typeStatusApplicant
2024-08-01U001Besponsa351(a)RxWyeth Pharmaceuticals LLC
2022-04-01U001Besponsa351(a)RxWyeth Pharmaceuticals LLC
2020-08-01U001Besponsa351(a)RxWyeth Pharmaceuticals Inc.
2020-05-01R001Besponsa351(a)RxWyeth Pharmaceuticals Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-05-01001Besponsa351(a)RxLicensed2017-08-17