Published in Food and Drug Law Weekly, January 27th, 2006
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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