Vivitrol

Alkermes Announces Submission of Complete Response to FDA for Vivitrol New Drug Application

CAMBRIDGE, Mass., February 17, 2006 - Alkermes, Inc. (Nasdaq: ALKS) today announced the submission of a complete response to the approvable letter issued in December 2005 by the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Vivitrol (naltrexone for extended-release injectable suspension). Alkermes expects the FDA to classify the complete response as a Class 1 resubmission, under which the FDA will seek to complete its review of the resubmission within 60 days from the time of resubmission.

Vivitrol is under review for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support. In March 2005, Alkermes submitted an NDA for Vivitrol. In June 2005, Alkermes and Cephalon, Inc. entered into a collaboration agreement to develop and commercialize Vivitrol in the United States for the treatment of alcohol dependence.

Source: Alkermes, Inc.

Posted: February 2006

Related Articles

• FDA Approves Vivitrol to Treat Opioid-dependent Patients - October 13, 2010
• Vivitrol Approved - Alkermes Inc. and Cephalon Inc - Treatment for Alcohol Dependence - April 13, 2006
• FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence - December 28, 2005
• FDA Extends PDUFA Date for Vivitrex to December 30, 2005 - September 20, 2005
• Alkermes Announces Priority Review Granted For Vivitrex (Naltrexone Long-Acting Injection) NDA Submission - May 27, 2005
• Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence - April 1, 2005

Vivitrol (naltrexone) FDA Approval History

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