News Report | December 22, 2019
FDA Revokes Buprenorphine Orphan Drug Designation
On November 7, 2019, the U.S. Food and Drug Administration (FDA) issued two separate decisions with respect to injectable buprenorphine products for the treatment of opioid use disorder (OUD). In response to a Citizen Petition from Braeburn Inc., the FDA revoked Indivior PLC’s orphan drug designation for a long-acting injectable buprenorphine for the treatment of OUD. The FDA had previously granted buprenorphine orphan drug designation for “opiate addiction in opiate users” in 1994. In a separate decision, the FDA reaffirmed its earlier determination that a monthly buprenorphine injection called BRIXADI, manufactured and marketed by Braeburn, Inc., falls . . .