Joint Drugs Advisory Committee Meeting: Anesthetic and Analgesic Products and Drug Safety and Risk Management

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Wednesday, February 14, 2018
8:00 am – 12:30 pm

Location: Silver Spring, MD

Date: February 14, 2018, 8:00 am to 12:30 pm

Location: FDA White Oak Campus, Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Agenda: The committees will be asked to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees will also be asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved.

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