approval · primary record
OMAVELOXOLONE
FDA · NDA · 2026-04-07
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Action date | 2026-04-07 |
| Brand | SKYCLARYS |
| Sponsor | BIOGEN US |
| Route | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-28T02:35:16.843Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: FDA:OMAVELOXOLONE:2026-04-07
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