Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Wednesday, December 11, 2019
FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug
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 dependence, following opioid detoxification and should be part of a comprehensive management program that includes psychosocial support. Known as medication-assisted treatment, the use of medications like Vivitrol, in combination with counseling and behavioral therapies, is effective in the treatment of opioid use disorder (OUD) and can help some people to sustain recovery. The warning letter was issued in relation to a print advertisement about Vivitrol. While the print advertisement contains claims and representations about the drug’s benefits, it fails to ...