← FDA DRUG APPROVALS

FDA NDA · NDA216718

SKYCLARYS

omaveloxolone

Sponsor: BIOGEN US

APPLICATION
NDA216718
TYPE
NDA
ORIGINAL APPROVAL
2023-02-28
LATEST ACTION
2026-04-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SKYCLARYS · ReferencePrescription
OMAVELOXOLONE 50MG · CAPSULE · ORAL

Approval history

2026-04-07Labeling · Supplement 14 · standard — Letter ↗AP
2024-12-20Efficacy · Supplement 8 · standard — Label ↗AP
2024-12-20Labeling · Supplement 9 · standard — Label ↗AP
2024-01-25Labeling · Supplement 2 · standard — Label ↗AP
2023-02-28Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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