Lanoxin, Lanoxin Pediatric

Treats mild to moderate heart failure. NDA 9330, held by Azurity. Digoxin.

As of Nov 13, 2026, NDA 9330 (Lanoxin, Lanoxin Pediatric), held by Azurity, was first approved by FDA on Nov 16, 1954, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 16, 1954
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LANOXIN 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 adults with chronic atrial fibrillation. 1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. LANOXIN 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Nov 16, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Lanoxin0.25MG/ML · injectable;injection	Digoxin	DiscontinuedReference drug
Lanoxin Pediatric0.1MG/ML · injectable;injection	Digoxin	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Oct 9, 2025	Supplement 40Labeling · Standard review	Approved	Label
Jun 20, 2024	Supplement 39Labeling · Standard review	Approved	Label Letter
Nov 2, 2022	Supplement 36Labeling · Standard review	Approved	Label Letter
Sep 20, 2018	Supplement 33Labeling · Standard review	Approved	Label Letter
Aug 24, 2018	Supplement 34Labeling · Standard review	Approved	Label Letter
Dec 1, 2016	Supplement 31Labeling · Standard review	Approved	Letter Label
Jul 28, 2015	Supplement 30Labeling · Standard review	Approved	Label Letter
May 16, 2013	Supplement 27Labeling	Approved	Letter Label
Nov 14, 2011	Supplement 26Labeling	Approved	Letter Label
Feb 5, 2010	Supplement 25Labeling	Approved	Letter Label
Jun 17, 2002	Supplement 21Manufacturing	Approved	Letter
Jul 15, 1998	Supplement 20Labeling · Standard review	Approved	Review
Jun 25, 1996	Supplement 18Labeling · Standard review	Approved	None posted
Aug 30, 1995	Supplement 17Labeling · Standard review	Approved	None posted
Aug 6, 1993	Supplement 16Manufacturing	Approved	None posted
May 7, 1992	Supplement 15Labeling	Approved	None posted
Sep 6, 1991	Supplement 14Manufacturing	Approved	None posted
Nov 16, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 9330
Drugs@FDA: Overview at FDA
Company: Azurity 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