Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats acute attacks of hereditary angioedema (HAE). Sold as Firazyr. Every FDA application for this active ingredient: 1 branded and 10 generic.
As of Nov 15, 2026, FDA lists 11 applications for Icatibant Acetate (sold as Firazyr), first approved Aug 25, 2011, with 0 new uses approved and 0 published complete response letters.
First approved: Aug 25, 2011
Applications: 11
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $79.6M
First approved in the EU: Jul 11, 2008
First approved in Japan: Sep 21, 2018
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 85 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
FirazyrA drug with a new additional pediatric dosage indicated for the treatment of acute attacks of hereditary angioedema. · Takeda Pharmaceutical Company Limited · Aug 24, 2022
Firazyr, new ingredientA drug with a new active ingredient indicated for the treatment of acute attacks of hereditary angioedema. · Shire Japan KK · Sep 21, 2018
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Fresenius Kabi USA
Cipla
Eugia Pharma
Alembic