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Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee ([AADPAC]) and the Nonprescription Drugs Advisory Committee (NDAC)

  • IQVIA Solutions Denmark A/S Denmark (map)

On Wednesday, February 15, 2023, the Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee ([AADPAC]) and the Nonprescription Drugs Advisory Committee (NDAC) will discuss a supplemental new drug application (sNDA- 208411/S–006) for NARCAN (naloxone hydrochloride) nasal spray, 4 mg/0.1 mL, submitted by Emergent BioSolutions Inc proposed for nonprescription treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The issues for discussion will be on the adequacy of the data supporting the nonprescription application. NARCAN represents a potential first in class product in a new therapeutic category for nonprescription drugs.

Source:: https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-15-2023-joint-meeting-nonprescription-drugs-advisory-committee-and-anesthetic-and-analgesic#event-materials
Earlier Event: February 9
Oncologic Drugs Advisory Committee
Later Event: February 28
Vaccines and Related Biological Products Advisory Committee ([VRBPAC])