BLA 761367, held by Csl Behring LLC. Garadacimab-Gxii.
As of Nov 13, 2026, BLA 761367 (Andembry), held by Csl Behring LLC, was first approved by FDA on Jun 16, 2025, with 0 approved supplements and 1 published complete response letter.
ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 7, 2024 | CSL312 (garadacimab)Facility Inspections, Microbiology, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Andembry200MG/1.2ML · injectable;subcutaneous | Garadacimab-Gxii | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
