Legal status by country
Is Icatibant legal?
Written by Aaron CuhaReviewed Sep 2026
How Icatibant is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Not approved | Not approved | Not approved |
| Classification | FDA-approved, prescription only | Prescription only; check current MHRA status | Prescription only; check current TGA status | Prescription only; check current Health Canada status |
| Note | FIRAZYR, NDA 022150, approved 25 August 2011, listed Prescription on 11 September 2026, with 6 generic icatibant acetate injections also listed Prescription. | None recorded | None recorded | None recorded |
US FDA status: FDA approved 25 August 2011 (FIRAZYR, NDA 022150) for acute attacks of hereditary angioedema in adults, subcutaneous injection. Listed Prescription on the 11 September 2026 Drugs@FDA query, alongside 6 generic icatibant acetate products approved between 2019 and 2024. It is an acute treatment, not a prophylactic, and it is not approved for ACE inhibitor-induced angioedema.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.