Addiction Medicine

Agency issues approvable letter for Vivitrol for treatment of alcohol dependence

Published in Medical Letter on the CDC and FDA, January 29th, 2006

Alkermes, Inc., (ALKS) and Cephalon, Inc., (CEPH) announced that the U.S. Food & Drug Administration (FDA) issued an approvable letter for Vivitrol (naltrexone for extended-release injectable suspension), which is under review for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support.

The new drug application (NDA) for Vivitrol, formerly known as Vivitrex, was submitted on March 31, 2005. Alkermes and Cephalon continue to prepare for the launch of Vivitrol during the second quarter of 2006.

FDA approval of Vivitrol is contingent upon finalizing the product label and satisfying a request by the...

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Source: Medical Letter on the CDC and FDA (2006-01-29)

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