Treats acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia. ANDA 204146, held by Avet Lifesciences. Ibutilide Fumarate.
As of Nov 15, 2026, ANDA 204146 (Ibutilide Fumarate), held by Avet Lifesciences, was first approved by FDA on Apr 1, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to ibutilide fumarate. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration. LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT Ibutilide fumarate can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ibutilide Fumarate0.1MG/ML · injectable;injection | Ibutilide Fumarate | 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
