US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade

Orphan drug designation for Indivior PLC’s Sublocade (buprenorphine extended-release) was improperly granted 25 years ago under the Orphan Drug Act’s cost recovery provision and should be revoked, the US Food and Drug Administration said in a first-of-its kind decision.

Based on the facts and circumstances at the time buprenorphine first received orphan drug designation for opioid addiction in 1994, it was unreasonable to conclude that there would be no cost recovery from the product’s sales in the US during its first seven years on the market, the agency said in a 7 November