Addiction Medicine

Priority review granted for Vivitrex

Published in Medical Letter on the CDC and FDA, July 3rd, 2005

Alkermes, Inc., (ALKS) announced that the New Drug Application (NDA) for Vivitrex (naltrexone long-acting injection) has been accepted for review by the U.S. Food and Drug Administration (FDA) and has been granted a Priority Review designation.

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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Source: Medical Letter on the CDC and FDA (2005-07-03)

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