Is Icatibant legal in the US?
Yes, FDA approved for sudden swelling attacks in adults with hereditary angioedema.
AStrong human evidenceFDA approvedas of 2026-10-26
Icatibant is FDA-approved as Firazyr, approved August 25, 2011, for treating acute attacks of hereditary angioedema in adults, given by subcutaneous self-injection. Generic icatibant injections have been approved since 2020. 21
Yes. It is sold as Firazyr and has been since August 2011. It treats acute attacks of hereditary angioedema in adults aged 18 and older. Several generic versions have been approved since 2020. 21
More on Icatibant
Citations
- Lumry 2011, Annals of Allergy, Asthma and Immunology: randomised placebo-controlled trial of icatibant for acute attacks of hereditary angioedema (FAST-3) doi.org
- NDC List: Firazyr (icatibant injection) label ndclist.com
Reference information only, not medical advice. Drawn from the Icatibant article, fact-checked against the cited sources. No dosing anywhere on this site.