Treats acute attacks of hereditary angioedema (HAE). ANDA 210118, held by Teva Pharms USA. Icatibant Acetate.
As of Nov 15, 2026, ANDA 210118 (Icatibant Acetate), held by Teva Pharms USA, was first approved by FDA on Jul 15, 2019, with 3 approved supplements 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 |
|---|---|---|---|
| Jul 15, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Icatibant AcetateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · injectable;subcutaneous | Icatibant Acetate | Rx |
| Sep 3, 2024 | Supplement 6Manufacturing | Approved | None posted |
| Jul 18, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 25, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 15, 2019 | Original application | Approved |
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
