FDA Advisors Endorse Moving Naloxone Over the Counter

by Michael DePeau-Wilson: For Complete Post, Click Here…

“A very important step from a public health perspective,” says panelist.

Advisors to the FDA unanimously recommended the agency approve the first over-the-counter (OTC) naloxone (Narcan) product, though many committee members expressed continued concern about user instructions for the opioid overdose reversal drug.

By a vote of 19-0 on Wednesday, members of both the Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee said the impressive safety and risk-benefit profile support approval of the nonprescription naloxone spray, which would allow for an unprecedented expansion of access.

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