ACTIVE SUBSTANCE / INN

EDOXABAN

Brand name(s): EDOXABAN, Roteas, Lixiana
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA213064
Stroke;Venous Thromboembolism
ACTIVE SUBSTANCE
Edoxaban
REGULATORS
FDA · EMA
SPONSORS / MAH
Berlin-Chemie AG, ZYDUS PHARMS USA INC, Daiichi Sankyo Europe GmbH
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
EDOXABANANDA213064ZYDUS PHARMS USA INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RoteasBerlin-Chemie AGAuthorised19/04/2017Stroke;Venous Thromboembolism
LixianaDaiichi Sankyo Europe GmbHAuthorised19/06/2015Stroke;Venous Thromboembolism

FULL INTELLIGENCE ON EDOXABAN

Patent cliffs, clinical trials, pipeline data, AI-enriched regulatory signals — free on PharmaSignal.

OPEN PLATFORM →