Treats mild to moderate heart failure. ANDA 215307, held by Novitium Pharma. Digoxin.
As of Nov 13, 2026, ANDA 215307 (Digoxin), held by Novitium Pharma, was first approved by FDA on Nov 22, 2021, with 1 approved supplement and 0 published complete response letters.
Digoxin is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. Increasing myocardial contractility in pediatric patients with heart failure. Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. 1.1 Heart Failure in Adults Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2021 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 22, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
