Published in Medical Letter on the CDC and FDA, July 3rd, 2005
The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the Vivitrex NDA is September 30, 2005. Vivitrex is being developed as the first long-acting medication available for the treatment of alcohol dependence (in conjunction with counseling) that is administered once-monthly, or every 4 weeks, by injection.
"We believe that the acceptance of our Vivitrex NDA for review is...
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