Icatibant Acetate

Treats acute attacks of hereditary angioedema (HAE). ANDA 212446, held by Cipla. Icatibant Acetate.

As of Nov 15, 2026, ANDA 212446 (Icatibant Acetate), held by Cipla, was first approved by FDA on Jul 13, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 13, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. SAJAZIR (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 13, 2020	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Icatibant AcetateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · injectable;subcutaneous	Icatibant Acetate	Rx

All 3 submissions, including labeling and manufacturing supplements


Jul 24, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Jun 3, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Jul 13, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 212446
Drugs@FDA: Overview at FDA
Company: Cipla

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