Alkermes Announces Submission Of Complete Response To FDA For VIVITROL(TM) New Drug Application

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 17, 2006--Alkermes, Inc. (Nasdaq: ALKS) today 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.
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