Alkermes Inc. April 13 announced that it has submitted a supplemental new drug application for Vivitrol (naltrexone extended-release injectable suspension) to the Food and Drug Administration for approval as a treatment for opioid dependence.
The Waltham, Mass.-based company said it requested a priority review for the application and if granted by FDA, it would mean a six-month review timeline.
Vivitrol is an opioid antagonist administered once a month by intramuscular injection and is approved by FDA for the treatment of alcohol dependence, Alkermes said. If approved by FDA for the treatment of opioid dependence, Vivitrol would be the first and ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.