Treats acute attacks of hereditary angioedema (HAE). ANDA 213773, held by Alembic. Icatibant Acetate.
As of Nov 15, 2026, ANDA 213773 (Icatibant Acetate), held by Alembic, was first approved by FDA on Jun 14, 2024, with 0 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 |
|---|---|---|---|
| Jun 14, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Icatibant AcetateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · injectable;subcutaneous | Icatibant Acetate | Rx |
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
