omaveloxolone

FDA Drug Profile — SKYCLARYS

Drug Details

Generic Name
omaveloxolone
Brand Names
SKYCLARYS
Application Number
NDA216718
Sponsor
Biogen
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
OMAVELOXOLONE

Indications and Usage

1 INDICATIONS AND USAGE SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. ( 1 )