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SKYCLARYS

Active substance: omaveloxolone

CAPSULE · OMAVELOXOLONE 50 mg/1

United StatesActive

Marketing holder: Biogen

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Skyclarys
    omaveloxolone
    EMEA/H/C/006084
    Biogen Netherlands B.V.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12092-4874-70cf-ba74-78d7f68f9868;count=1 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
64406-250
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 64406-250 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 64406-250 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 64406-250 · Verified 2026-10-09 · open in source