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Alkermes Vivitrex gets priority review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Alkermes' Vivitrex has a Sept. 30 user fee date following FDA's priority review designation for the long-acting naltrexone injection. Vivitrex would be the first once-monthly injection product for treatment of alcoholism; Alkermes has been highlighting the formulation's potential compliance benefit over current alcoholism treatments, most of which are oral (1Pharmaceutical Approvals Monthly April 2005, p. 8). Vivitrex utilizes the company's Medisorb microsphere delivery technology...

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