Tag: medication assisted treatment

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

For Immediate Release:December 11, 2019 The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials. Vivitrol is approved for the prevention of relapse to opioid … Continue reading FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug