For atrial fibrillation/atrial flutter of greater than one week duration. ANDA 212750, held by Granules. Dofetilide.
As of Nov 13, 2026, ANDA 212750 (Dofetilide), held by Granules, was first approved by FDA on Oct 14, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsule is 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 capsule 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 14, 2021 | 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 |
|---|---|---|---|
| Apr 30, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 14, 2021 | 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
