FDAnews Drug Daily Bulletin

Zohydro ER Rejected by FDA Panel Due to Abuse Potential

Dec. 18, 2012
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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