Treats acute attacks of hereditary angioedema (HAE). ANDA 213521, held by Eugia Pharma. Icatibant Acetate.
As of Nov 15, 2026, ANDA 213521 (Icatibant Acetate), held by Eugia Pharma, was first approved by FDA on Aug 14, 2023, with 1 approved supplement and 0 published complete response letters.
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Icatibant injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Icatibant AcetateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · injectable;subcutaneous | Icatibant Acetate | Rx |
| Oct 22, 2024 | Supplement 2Manufacturing | Approved | None posted |
| Aug 14, 2023 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
