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Treats mild to moderate heart failure. NDA 21648, held by Hikma. Digoxin.
As of Nov 15, 2026, NDA 21648 (Digoxin), held by Hikma, was first approved by FDA on Aug 26, 2004, with 9 approved supplements and 0 published complete response letters.
First approved: Aug 26, 2004
Review: Standard
Supplements approved: 9
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Digoxin is a cardiac glycoside indicated in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. ( 1.1, 1.3 ) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. 1.1 Heart Failure in Adults Digoxin Oral Solution is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by increased exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality.
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
