The FDA has issued new guidance for labeling buprenorphine-containing transmucosal products that seeks to clarify misinterpreted packaging for medications commonly used to treat patients with opioid dependence (BTOD), specifically regarding maximum daily dosages.
The new labeling guidelines apply only to transmucosal buprenorphine products, such as Suboxone (Indivior), Zubsolv (Orexo US) and generic transmucosal buprenorphine medications and clarify that 16 or 24 mg per day are not the maximum