Response Letter From The FDA To Braeburn, Inc. About The Claims Raised In The Citizen’s Petition About Orphan Drug Status For Buprenorphine

On November 7, 2019, the U.S. Food and Drug Administration responded to Braeburn, Inc.'s petition to revoke Indivior Inc.'s orphan-drug designation for Sublocade for treatment of opioid use disorder (OUD), and to refuse to grant orphan-drug exclusivity to Sublocade. The petition was granted in part, and will revoke Indivior's orphan-drug designation for buprenorphine for OUD treatment . . .