Alkermes Submits Vivitrex NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Alkermes' Vivitrex would be the first alcohol dependence treatment available in a once-monthly injection if FDA approves the NDA submitted March 31
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Cephalon/Alkermes Vivitrex User Fee Date Extended
FDA has extended the user fee date for Cephalon's and Alkermes' alcohol dependency therapy Vivitrex (naltrexone) by three months to Dec. 30, the companies announced Sept. 20
Cephalon/Alkermes Vivitrex User Fee Date Extended
FDA has extended the user fee date for Cephalon's and Alkermes' alcohol dependency therapy Vivitrex (naltrexone) by three months to Dec. 30, the companies announced Sept. 20
Vivitrex Will Launch With 25-100 Member Sales Force, Alkermes Says
The Vivitrex sales team will target 6,000 specialists that treat alcohol-dependent patients, CEO Pops says. Alkermes will then look to a marketing partner to expand Vivitrex use beyond the 2.3 mil. initial patient population, he says. Alkermes expects approval in 2006.