approval · primary record
OMAVELOXOLONE
FDA · NDA · 2026-04-07
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-04-07 |
| Approval events | 1 |
| Brand | SKYCLARYS |
| Sponsor | BIOGEN US |
| Route | ORAL |
Approval history
1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-04-07 | FDA | NDA | SKYCLARYS | BIOGEN US | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:30:25.812Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:omaveloxolone
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Omaveloxolone · compound