omaveloxolone

FDA Drug Profile — SKYCLARYS

omaveloxolone is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including SKYCLARYS. Available dosage form: capsule.

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 )