Quick answers
- What is Icatibant used for?
- The FDA-approved label (Firazyr, Takeda Pharmaceuticals America, Inc., July 7, 2025) says: “FIRAZYR ® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. FIRAZYR is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Icatibant have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Icatibant?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated May 7, 2026). Ask your pharmacist about alternatives.
- Has Icatibant been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Icatibant?
- 9 companies list prescription products of Icatibant in the FDA NDC Directory, including Cycle Pharmaceuticals Ltd-Uk, Hikma Pharmaceuticals USA Inc. and Eugia US LLC.
What Icatibant is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FIRAZYR ® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. FIRAZYR is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
— FDA label: Firazyr, Takeda Pharmaceuticals America, Inc., effective July 7, 2025. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Cycle Pharmaceuticals Ltd-Uk1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Eugia US LLC1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Takeda Pharmaceuticals America, Inc.1 product
- Fresenius Kabi USA, LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Cipla USA Inc.1 product
- Alembic Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022150 FIRAZYR | Takeda Pharms USA | August 25, 2011 | 10, latest January 19, 2024 2024: Manufacturing (CMC) · 2022: Labeling · 2020: Labeling |
Generic approvals (6)
- ANDA210118Teva Pharms USA · July 15, 2019
- ANDA211021Jiangsu Hansoh Pharm · March 9, 2020
- ANDA208317Fresenius Kabi USA · June 18, 2020
- ANDA212446Cipla · July 13, 2020
- ANDA213521Eugia Pharma · August 14, 2023
- ANDA213773Alembic · June 14, 2024
Shortage status
To be discontinued · updated May 7, 2026 · first posted May 7, 2026
| Product | Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-93) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1148141, 1148145, 2569480 |
|---|---|
| SPL set ID of the quoted label | ed6657ca-ab68-477a-9968-e12dc928b540 |
| FDA labels (SPL) | 9 |
| FDA applications | NDA022150, 6 ANDA |
| Active ingredients (FDA) | ICATIBANT ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Firazyr, Takeda Pharmaceuticals America, Inc., effective July 7, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →