← FDA Drug Approvals (Drugs@FDA)
SKYCLARYS
NDA · New Drug Application · Sponsor: BIOGEN US · Approved 2023-02-28
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown