For atrial fibrillation/atrial flutter of greater than one week duration. ANDA 207058, held by Dr Reddys Labs SA. Dofetilide.
As of Nov 13, 2026, ANDA 207058 (Dofetilide), held by Dr Reddys Labs SA, was first approved by FDA on Jun 6, 2016, 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 capsules 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 |
|---|---|---|---|
| Jun 6, 2016 | Original application | Approved |
| 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 |
|---|---|---|---|
| Feb 24, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 6, 2016 | 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
