Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
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The US state of Oklahoma has agreed to a settlement from Endo International after an investigation into its role in the opioid abuse crisis.
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.
Marketing authorisation has been recommended in the EU by an EMA committee for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.