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Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee – TARIUS – GLOBAL REGULATORY REQUIREMENTS
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Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee

November 2

The committees will discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Õlas Pharma, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term (not to exceed 3 days) management of acute post-operative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting.

Details

Date:
November 2
Event Category: