FDAnews Drug Daily Bulletin

Zohydro ER Rejected by FDA Panel Due to Abuse Potential

Dec. 18, 2012
An FDA advisory panel voted down Zogenix’s Zohydro ER due to concerns on its potential for abuse and addiction. In a 2–11 vote with one abstention, the panel on Dec. 7 voted against recommending approval for hydrocodone bitrate extended-release capsules, which would be classified as a Schedule II with “high potential for abuse.” If approved, the tablets would be the first single-entity hydrocodone analgesic.
Washington Drug Letter