Posted by Michael Wonder on 11 Nov 2019
FDA admits it goofed when granting orphan status to an opioid addiction treatment
8 November 2019 - In an unusual move, the FDA has acknowledged a mistake and revoked orphan drug status for an opioid addiction treatment that was approved two years ago, clearing the way for another injection of buprenorphine to possibly reach the market.
Specifically, the agency withdrew orphan designation and exclusivity for Sublocade, which was approved nearly two years and hailed as a potential game changer for combating the opioid crisis.
