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Vivitrol Approval History

FDA Approved: Yes (First approved April 13, 2006)
Brand name: Vivitrol
Generic name: naltrexone
Dosage form: Long-Acting Injection
Previous Name: Vivitrex
Company: Alkermes, Inc.
Treatment for: Alcohol Dependence

Vivitrol (naltrexone) is is an opioid antagonist indicated for the treatment of alcohol dependence and opioid dependence.

Development History and FDA Approval Process for Vivitrol

DateArticle
Oct 13, 2010Approval FDA Approves Vivitrol to Treat Opioid-dependent Patients
Apr 13, 2006Approval Vivitrol Approved - Alkermes Inc. and Cephalon Inc - 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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