FDA Recommends Changes to Labeling for Transmucosal Buprenorphine Products Indicated to Treat Opioid Use Disorder

Today, FDA issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs).