Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence

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The Food and Drug Administration (FDA, Agency, or we) is announcing that we have concluded that certain statements set forth in the FDA-approved labeling for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs) related to the recommended maintenance dosage and dosage adjustments during pregnancy can be modified. We believe that certain statements in BTOD labeling can be modified because the labeling for these products may be misinterpreted by some as establishing a maximum dosage when none exists. FDA is concerned that misinterpretation of these labeling statements may be adversely impacting patients' access to BTODs. We encourage sponsors of approved applications for BTODs to submit supplemental new drug applications (NDAs) (labeling supplements) to modify these labeling statements as described in this notice.