Extavia Purple Book BLA 125290

BLA number
125290
Proprietary names
Extavia
Proper names
interferon beta-1b
Applicant
Novartis Pharmaceuticals Corporation
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
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Extaviainterferon beta-1b351(a)0.3MGFor InjectionSubcutaneousSingle-Dose VialDiscVoluntarily Revoked2009-08-14

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
2024-01-01U001Extavia351(a)DiscNovartis Pharmaceuticals Corporation
2023-07-01U001Extavia351(a)DiscNovartis Pharmaceuticals Corporation
2020-05-01R001Extavia351(a)RxNovartis Pharmaceuticals Corporation

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2024-01-01001Extavia351(a)DiscVoluntarily Revoked2009-08-14
2023-07-01001Extavia351(a)DiscLicensed2009-08-14
2020-05-01001Extavia351(a)RxLicensed2009-08-14