WALTHAM, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company’s supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence. Notification of this potential advisory committee meeting follows a designation in May 2010 by the FDA of priority review of the VIVITROL sNDA, a designation that accelerates the FDA’s target review timeline from ten to six months for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. With priority review, the Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision regarding approval of the VIVITROL sNDA for opioid dependence is October 12, 2010.
