# DAWNZERA (AUTOINJECTOR)
> **NDA219407** · New Drug Application · Sponsor: IONIS PHARMS INC · Approved 2025-08-21
## Drug
- **FDA Application Number:** NDA219407
- **Application type:** New Drug Application
- **Brand name:** DAWNZERA (AUTOINJECTOR)
- **Generic name:** DONIDALORSEN
- **Active ingredients:** DONIDALORSEN SODIUM
- **Dosage form:** SOLUTION
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** IONIS PHARMS INC
- **Manufacturer:** Ionis Pharmaceuticals Inc.
- **First approval:** 2025-08-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219407)
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