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).
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Earlier Event: February 8Advisory Committee on Heritable Disorders in Newborns and Children
Later Event: February 14Anesthetic and Analgesic Drugs Advisory Committee