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
| Date | Article |
|---|
| 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 |
Further information
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