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FDA Medication Tracker

← All approvals · Rare & genetic · 2025

Andembry (garadacimab-gxii)

The FDA approved Andembry (garadacimab-gxii) on June 16, 2025 to prevent attacks of hereditary angioedema.
Brand name
Andembry
Generic name
garadacimab-gxii
FDA approval date
June 16, 2025
Approved use (FDA wording)
To prevent attacks of hereditary angioedema
Company
Csl Behring LLC
Application
BLA761367
Dosage form / route
INJECTABLE · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.