ARTICLE | Clinical News

Vivitrol naltrexone regulatory update

October 18, 2010 7:00 AM UTC

FDA approved an sNDA from Alkermes to extend the label for 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 (see BioCentury, Sept. 20). ...