Nexterone

Prevents frequently recurring ventricular fibrillation (VF) and hemodynamically unstable…. NDA 22325, held by Baxter Hlthcare. Amiodarone Hydrochloride.

As of Nov 15, 2026, NDA 22325 (Nexterone), held by Baxter Hlthcare, was first approved by FDA on Dec 24, 2008, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 24, 2008
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with NEXTERONE, patients may be transferred to oral amiodarone therapy. Use NEXTERONE for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but NEXTERONE may be safely administered for longer periods if necessary.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 24, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


Nexterone50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Amiodarone Hydrochloride	DiscontinuedReference drug
Nexterone150MG/100ML (1.5MG/ML) · injectable;injection	Amiodarone Hydrochloride	RxReference drug
Nexterone360MG/200ML (1.8MG/ML) · injectable;injection	Amiodarone Hydrochloride	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Feb 21, 2025	Supplement 19Labeling · Standard review	Approved	Letter Label
Sep 7, 2021	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 22, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label
Nov 22, 2016	Supplement 13Labeling · Standard review	Approved	Label Letter
Oct 31, 2016	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 13, 2015	Supplement 9Labeling · Standard review	Approved	Letter Label
Sep 29, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 8, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 23, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 29, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 5, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 4, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 12, 2011	Supplement 2Labeling	Approved	Letter Label
Nov 16, 2010	Supplement 1Manufacturing · Standard review	Approved	Review Letter Label
Dec 24, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22325
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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