Treats life-threatening ventricular arrhythmias. NDA 205108, held by Azurity. Sotalol Hydrochloride.
As of Nov 15, 2026, NDA 205108 (Sotylize), held by Azurity, was first approved by FDA on Oct 22, 2014, with 2 approved supplements and 0 published complete response letters.
SOTYLIZE is an antiarrhythmic indicated for: The treatment of life-threatening ventricular arrhythmias The maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) Limitations of Use SOTYLIZE has not been shown to enhance survival in patients with life threatening ventricular arrhythmias Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL 1.1 Life-Threatening Ventricular Arrhythmia SOTYLIZE is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2014 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sotylize5MG/ML (5MG/ML) · solution;oral | Sotalol Hydrochloride | RxReference drug |
| Jan 12, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Jun 16, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 22, 2014 | Original applicationNew dosage form · Standard review | 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
