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Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

On Wednesday morning, February 14, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee voted that Hydexor (proposed trade name), a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc. (Charleston), should not be approved, by a vote of 2-Yes to 19-No, with no abstentions. Hydexor contains hydrocodone, acetaminophen, and promethazine, and is proposed for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting (OINV).