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FDA approves expanded Vivitrol label

October 12, 2010 11:57 PM UTC

FDA approved an sNDA from Alkermes Inc. (NASDAQ:ALKS) to extend the label of Vivitrol naltrexone to prevent relapse to opioid use in opioid-dependent patients following opioid detoxification. In September, an FDA panel voted 12-1 to recommend approval of the sNDA based on efficacy data from a single Russian Phase III trial. ...