Alkermes Announced Submission of Complete Response to FDA for VIVITROL New Drug Application

21-Feb-2006

Alkermes, Inc. announced the submission of a complete response to the approvable letter issued in December 2005 by the U.S. food and Drug Administration (FDA) regarding the New Drug Application (NDA) for VIVITROL(TM) (naltrexone for extended-release injectable suspension). Alkermes expects the FDA to classify the complete response as a Class 1 resubmission, under which the FDA will seek to complete its review of the resubmission within 60 days from the time of resubmission.

VIVITROL is under review for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support.

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