Vivitrol FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved April 13, 2006)
Brand name: Vivitrol
Generic name: naltrexone
Dosage form: for Extended-Release Injectable Suspension
Previous Name: Vivitrex
Company: Alkermes, Inc.
Treatment for: Alcohol Use Disorder, Opiate Dependence
Vivitrol (naltrexone) is is an opioid antagonist indicated for the treatment of alcohol dependence and opioid dependence.
Development timeline for Vivitrol
|Oct 28, 2022||Last patient enrolled in study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/ naloxone for the treatment of OUD|
|Oct 13, 2022||BioCorRx Completes Final Subject Enrollment in Phase I Clinical Trial of BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder|
|Oct 13, 2010||Approval FDA Approves Vivitrol to Treat Opioid-dependent Patients|
|Apr 13, 2006||Approval FDA Approves Vivitrol (naltrexone) for the Treatment for Alcohol Dependence|
|Feb 17, 2006||Alkermes Announces Submission of Complete Response to FDA for Vivitrol New Drug Application|
|Dec 28, 2005||FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence|
|Sep 20, 2005||FDA Extends PDUFA Date for Vivitrex to December 30, 2005|
|May 27, 2005||Alkermes Announces Priority Review Granted For Vivitrex (Naltrexone Long-Acting Injection) NDA Submission|
|Apr 1, 2005||Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.