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.
