FDA revokes an opioid drug's orphan status

The FDA has owned up to a mistake, and will revoke the orphan drug status of an opioid addiction treatment called Sublocade approved two years ago. As a result, the drug’s maker, Indivior, will no longer have market exclusivity — and potential competitors can now seek approval.

Indivior was granted orphan status thanks to a loophole, as STAT’s Ed Silverman explains. But Sublocade is a modified version of a drug that Indivior sold for decades — and has already reaped billions of dollars in sales from.

Indivior, it should be noted, is currently facing federal charges for allegedly engaging in a multibillion-dollar fraudulent scheme to increase prescriptions of another of its opioid abuse therapies.