FDA Wants Labeling Changes for Buprenorphine

FDA has published a Federal Register notice to encourage companies to submit sNDAs to modify the labeling statements for buprenorphine-containing transmucosal products indicated to treat opioid dependence (BTODs). An agency statement (contains a link to the Federal Register notice) says the agency has received feedback from multiple interested parties indicating a misperception by some that labeling for BTODs includes a maximum daily dose.

“In fact,” FDA says, “the labeling does not specify a maximum dose. We also received similar feedback through several meetings in which FDA participated…. For this reason, FDA is recommending revisions of BTOD labeling to avoid misinterpretation of dosing information.”

The notice says the changes are intended for transmucosal buprenorphine products only, such as Indivior’s Suboxone (buprenorphine and naloxone), Orexo’s Zubsolv (buprenorphine and naloxone), and other generic transmucosal buprenorphine medications.