FDA to re­voke or­phan des­ig­na­tion for opi­oid ad­dic­tion drug Sublo­cade

The FDA said Thurs­day that it has de­cid­ed to re­voke the or­phan des­ig­na­tion grant­ed to In­di­v­ior’s opi­oid use dis­or­der (OUD) treat­ment Sublo­cade (buprenor­phine ex­tend­ed-re­lease in­jec­tion).

Ap­proved as a sub­lin­gual tablet in 2002 and known as Sub­u­tex (buprenor­phine), the drug re­ceived or­phan des­ig­na­tion and sev­en years of ex­clu­siv­i­ty thor­ough 2009. In 2017, the FDA ap­proved In­di­v­ior’s ex­tend­ed re­lease in­jec­tion of buprenor­phine, known as Sublo­cade.

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