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SKYCLARYS (Biogen Australia Pty Ltd)
Product name
SKYCLARYS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
144 (255 working days)
Active ingredients
omaveloxolone
Registration type
NCE/ NBE
Indication
SKYCLARYS is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.