Vivitrex 90-day extension
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's user fee deadline for Cephalon/Alkermes' once-monthly injectable naltrexone formulation Vivitrex is Dec. 30 following a 90-day extension, the firms announce Sept. 20. The extension stems from a recent response being reclassified as a major amendment. Vivitrex is receiving a priority review for treatment of alcoholism (1Pharmaceutical Approvals Monthly June 2005, In Brief)...
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