For atrial fibrillation/atrial flutter of greater than one week duration. ANDA 208625, held by Bionpharma. Dofetilide.
As of Nov 13, 2026, ANDA 208625 (Dofetilide), held by Bionpharma, was first approved by FDA on Apr 10, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 10, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dofetilide0.125MG · capsule;oral | Dofetilide | Rx |
| Dofetilide0.25MG · capsule;oral | Dofetilide | Rx |
| Dofetilide0.5MG · capsule;oral | Dofetilide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 28, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 10, 2018 | 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
