FDA Proposes Revisions to Opioid Treatment Drug Labeling Amid Concerns Over Dosage Misinterpretation
December 27, 2024
December 27, 2024
WASHINGTON, Dec. 27 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has announced plans to revise specific statements in the labeling of buprenorphine-containing transmucosal products used for treating opioid dependence (BTODs). The agency aims to address concerns that the current language, which refers to "target" dosages and specifies no clinical advantage for dosages higher than 24 mg per day, may inadvertently mislead healthcare providers and restrict patient access to appro . . .