Alkermes says FDA approved company's response to agency's approval letter on Vivitrol

By Ted A. Knutson

Washington, March 7 - Alkermes, Inc. said the Food and Drug Administration on March 1 notified it that the company's response to the FDA's approvable letter for the Vivitrol (naltrexone for extended-release injectable suspension) New Drug Application was a complete, class I response.

Under the Prescription Drug User Fee Act, the FDA has set a targeted response date of April 16.

In June Alkermes and Cephalon, Inc. entered into a collaboration to develop and commercialize Vivitrol in the United States for the treatment of alcohol dependence.

Alkermes is a Cambridge, Mass.-based pharmaceutical company that develops products based on sophisticated drug delivery technologies to enhance therapeutic outcomes in major diseases.

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