FDA.reportPublic FDA data

Novoseven, Novoseven Rt Purple Book BLA 103665

BLA number
103665
Proprietary names
Novoseven, Novoseven Rt
Proper names
Coagulation Factor VIIa (Recombinant)
Applicant
Novo Nordisk Inc.
Center
CBER
First observed release
2020-08-01
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
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)351(a)2.4MGFor InjectionIntravenousSingle-Dose VialDiscLicensed1999-03-25
002Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)351(a)1.2MGFor InjectionIntravenousVialDiscLicensed2000-11-15
003Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)351(a)4.8MGFor InjectionIntravenousVialDiscLicensed2000-11-15
004Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)351(a)5.0MGFor InjectionIntravenousSingle-Dose VialRxLicensed2008-05-09
005Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)351(a)1.0MGFor InjectionIntravenousSingle-Dose VialRxLicensed2008-05-09
006Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)351(a)2.0MGFor InjectionIntravenousSingle-Dose VialRxLicensed2008-05-09
007Novoseven, Novoseven RtCoagulation Factor VIIa (Recombinant)351(a)8.0MGFor InjectionIntravenousSingle-Dose VialRxLicensed2010-08-06

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
2021-09-01U001Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2021-09-01U002Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2021-09-01U003Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2021-09-01U004Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2021-09-01U005Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2021-09-01U006Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2021-09-01U007Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2021-05-01U001Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2021-05-01U002Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2021-05-01U003Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2021-05-01U004Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2021-05-01U005Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2021-05-01U006Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2021-05-01U007Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2020-08-01R001Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2020-08-01R002Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2020-08-01R003Novoseven, Novoseven Rt351(a)DiscNovo Nordisk Inc.
2020-08-01R004Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2020-08-01R005Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2020-08-01R006Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.
2020-08-01R007Novoseven, Novoseven Rt351(a)RxNovo Nordisk Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2020-08-01001Novoseven, Novoseven Rt351(a)DiscLicensed1999-03-25
2020-08-01002Novoseven, Novoseven Rt351(a)DiscLicensed2000-11-15
2020-08-01003Novoseven, Novoseven Rt351(a)DiscLicensed2000-11-15
2020-08-01004Novoseven, Novoseven Rt351(a)RxLicensed2008-05-09
2020-08-01005Novoseven, Novoseven Rt351(a)RxLicensed2008-05-09
2020-08-01006Novoseven, Novoseven Rt351(a)RxLicensed2008-05-09
2020-08-01007Novoseven, Novoseven Rt351(a)RxLicensed2010-08-06