For atrial fibrillation/atrial flutter of greater than one week duration. ANDA 210466, held by Sun Pharm. Dofetilide.
As of Nov 13, 2026, ANDA 210466 (Dofetilide), held by Sun Pharm, was first approved by FDA on Oct 9, 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 |
|---|---|---|---|
| Oct 9, 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 |
|---|---|---|---|
| Dec 11, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 9, 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
