Vivitrol

Treats alcohol dependence. NDA 21897, held by Alkermes. Naltrexone.

As of Nov 14, 2026, NDA 21897 (Vivitrol), held by Alkermes, was first approved by FDA on Apr 13, 2006, with 27 approved supplements and 0 published complete response letters.

First approved: Apr 13, 2006
Review: Priority
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Treatment with naltrexone for extended-release injectable suspension should be part of a comprehensive management program that includes psychosocial support. Naltrexone for extended-release injectable suspension contains naltrexone, an opioid antagonist, and is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with naltrexone for extended-release injectable suspension. Patients should not be actively drinking at the time of initial naltrexone for extended-release injectable suspension administration.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


Oct 12, 2010	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 13, 2006	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vivitrol380MG/VIAL · for suspension, extended release;intramuscular	Naltrexone	RxReference drug

All 28 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 61Labeling · Standard review	Approved	Label Letter
Sep 30, 2022	Supplement 57Labeling · Standard review	Approved	Label
May 6, 2021	Supplement 55REMS	Approved	Letter
Mar 4, 2021	Supplement 52Labeling · Standard review	Approved	Label Medication Guide Letter
May 8, 2020	Supplement 49Labeling · Standard review	Approved	Label Letter
Sep 6, 2019	Supplement 45Labeling · Standard review	Approved	Letter Label
Jun 7, 2019	Supplement 44REMS	Approved	None posted
Dec 28, 2018	Supplement 42Labeling · Standard review	Approved	Label Letter
Dec 12, 2016	Supplement 35Manufacturing · Standard review	Approved	None posted
Dec 9, 2016	Supplement 33Manufacturing · Standard review	Approved	None posted
May 20, 2016	Supplement 32REMS	Approved	Letter
May 19, 2016	Supplement 31Manufacturing · Priority review	Approved	None posted
Jan 19, 2016	Supplement 30Manufacturing · Priority review	Approved	None posted
Dec 8, 2015	Supplement 29Manufacturing · Priority review	Approved	Letter Label
Jan 26, 2015	Supplement 28Manufacturing · Priority review	Approved	None posted
Aug 29, 2014	Supplement 27Manufacturing · Priority review	Approved	None posted
Apr 17, 2014	Supplement 26Manufacturing · Priority review	Approved	None posted
Feb 9, 2014	Supplement 24Manufacturing · Priority review	Approved	None posted
Jan 7, 2014	Supplement 25Manufacturing · Priority review	Approved	None posted
Jul 29, 2013	Supplement 20REMS	Approved	Label Letter
Jul 29, 2013	Supplement 23Labeling · Standard review	Approved	Label Letter
Mar 28, 2013	Supplement 21Manufacturing · Priority review	Approved	None posted
Oct 12, 2010	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 18, 2010	Supplement 6Manufacturing	Approved	None posted
Mar 22, 2010	Supplement 5Labeling · Standard review	Approved	Label Letter
Mar 22, 2010	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 26, 2007	Supplement 3Labeling · Standard review	Approved	Letter Label
Apr 13, 2006	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21897
Drugs@FDA: Overview at FDA
Company: Alkermes

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