HOME › DRUGS › OMAVELOXOLONE
ACTIVE SUBSTANCE / INN

OMAVELOXOLONE

Brand name(s): SKYCLARYS, Skyclarys
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Friedreich Ataxia
NDA216718
ACTIVE SUBSTANCE
Omaveloxolone
REGULATORS
FDA · EMA
SPONSORS / MAH
Biogen Netherlands B.V., BIOGEN US
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SKYCLARYSNDA216718BIOGEN USPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SkyclarysBiogen Netherlands B.V.Authorised09/02/2024Friedreich Ataxia

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