# SKYCLARYS
> **NDA216718** · New Drug Application · Sponsor: BIOGEN US · Approved 2023-02-28
## Drug
- **FDA Application Number:** NDA216718
- **Application type:** New Drug Application
- **Brand name:** SKYCLARYS
- **Generic name:** OMAVELOXOLONE
- **Active ingredients:** OMAVELOXOLONE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** BIOGEN US
- **Manufacturer:** Biogen
- **First approval:** 2023-02-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216718)
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