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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, 2022Last patient enrolled in study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/ naloxone for the treatment of OUD
Oct 13, 2022BioCorRx Completes Final Subject Enrollment in Phase I Clinical Trial of BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder
Oct 13, 2010Approval FDA Approves Vivitrol to Treat Opioid-dependent Patients
Apr 13, 2006Approval FDA Approves Vivitrol (naltrexone) for the Treatment for Alcohol Dependence
Feb 17, 2006Alkermes Announces Submission of Complete Response to FDA for Vivitrol New Drug Application
Dec 28, 2005FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence
Sep 20, 2005FDA Extends PDUFA Date for Vivitrex to December 30, 2005
May 27, 2005Alkermes Announces Priority Review Granted For Vivitrex (Naltrexone Long-Acting Injection) NDA Submission
Apr  1, 2005Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence

Further information

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