Labeling for Opioid Dependence Treatment Can Be Modified to Clarify Dosage Recs, FDA Says
The FDA has determined that agency-approved labeling for buprenorphine-containing transmucosal products to treat opioid dependence (BTODs) can be modified to clarify dosage recommendations to broaden access to the drug, it said in a notice.
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Labeling may be changed to reflect recommended maintenance dosage and dosage adjustments during pregnancy, according to the FDA.
"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," the FDA said. "FDA is concerned that misinterpretation of these labeling statements may be adversely impacting patients’ access to BTODs."
The agency said it's encouraging sponsors of approved applications for BTODs to submit supplemental new drug applications, or labeling supplements, to modify these labeling statements as described in the notice.