FDA changes buprenorphine labeling to favor higher doses

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In December, the Food and Drug Administration (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). BTODs are medications that are dissolved in the mouth and contain buprenorphine, or a combination of buprenorphine and naloxone, and are indicated to treat opioid use disorder (OUD)—previously referred to as opioid dependence.