NDA 219407, held by Ionis Pharms Inc. Donidalorsen Sodium.
As of Nov 13, 2026, NDA 219407 (Dawnzera (Autoinjector)), held by Ionis Pharms Inc, was first approved by FDA on Aug 21, 2025, with 0 approved supplements and 0 published complete response letters.
DAWNZERA is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dawnzera (Autoinjector)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) · solution;subcutaneous | Donidalorsen Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
