Sotalol Hydrochloride

Treats life-threatening ventricular tachycardia. NDA 22306, held by Altathera Pharms LLC. Sotalol Hydrochloride.

As of Nov 13, 2026, NDA 22306 (Sotalol Hydrochloride), held by Altathera Pharms LLC, was first approved by FDA on Jul 2, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 2, 2009
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sotalol is an antiarrhythmic indicated for: the treatment of life-threatening ventricular tachycardia. the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL). Limitations of Use Sotalol 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 Sotalol is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia in adult and pediatric patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Jul 23, 2025	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 6, 2020	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 2, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sotalol Hydrochloride150MG/10ML (15MG/ML) · solution;intravenous	Sotalol Hydrochloride	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Jul 23, 2025	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 21, 2023	Supplement 6Labeling · Standard review	Approved	Letter Label
Mar 6, 2020	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 25, 2015	Supplement 4Manufacturing	Approved	None posted
Jun 6, 2013	Supplement 3Manufacturing	Approved	None posted
Jul 2, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22306
Drugs@FDA: Overview at FDA
Company: AltaThera Pharmaceuticals

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