FDA Committees Vote Unanimously To Recommend Approval For OTC Naloxone

Psychiatric News (2/21) reports that last week, the FDA ‘s “Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously, 19-0, to recommend that Narcan (naloxone HCl) 4 mg nasal spray be made available without a prescription, Emergent BioSolutions announced” in a Feb. 15 press release. Naloxone “reverses an opioid overdose by blocking the effects of opioids.” While the agency “is not bound by the committees’ guidance,” it “will take their advice into consideration when it makes its decision on whether to make the drug available over the counter (OTC).” The approval decision is “expected by March 29.”

Related Links:

— “FDA Advisory Panel Recommends Approval for Over-the-Counter Narcan, Psychiatric News, February 21, 2023

Posted in In The News.