FDA Revokes Sublocade Orphan Drug Designation

Responding to a 4/5 Braeburn petition, FDA says it is revoking, as improperly granted, Indivior’s orphan drug designation for Sublocade (buprenorphine) for treating opiate addiction in opiate users. The agency’s response to Braeburn says the orphan drug designation was predicated on a demonstration that there was “no reasonable expectation” that the cost of developing and marketing in the U.S. buprenorphine for opioid use disorder could be recovered from U.S. sales of the drug.

The agency says that a reevaluation of the administrative record in light of the materials in the docket and additional relevant information has shown that FDA erroneously granted Indivior’s orphan drug designation request because, on the basis of facts and circumstances as of the date of the orphan designation request, it was unreasonable to conclude that there would be no cost recovery from sales of buprenorphine in the U.S.