This decision was eagerly awaited to deal with the opioid crisis ravaging the United States, as it will expand access to this nasal spray, authorized since 2015.
It will allow it to be purchased freely "in pharmacies, supermarkets, gas stations or on the internet," the FDA said in a statement.
Narcan uses a molecule called naloxone, which works by replacing opioids on receptors in the brain previously activated by these synthetic opiates, including the powerful fentanyl.
"It makes you come back from the dead," Johnny Bailey, who works for a drug user aid association in Washington, HIPS, told AFP earlier this month.
The FDA's decision is only about nasal spray with a concentration of 4 milligrams of naloxone. For other dosages, a prescription will always be required.
It is now up to the manufacturer of Narcan, Emergent BioSolutions, to determine the level of production and the selling price.
A building at the headquarters of the US Food and Drug Administration (FDA) in July 2020 in Maryland © Sarah Silbiger / GETTY IMAGES NORTH AMERICA / AFP
"We encourage the manufacturer to (...) make it available as quickly as possible at an affordable price," FDA chief Robert Califf said in the statement.
Since 2015, millions of doses of Narcan have already been prescribed or distributed directly by associations, or even in pharmacies in states that allow it.
But the worsening opioid crisis, which caused 81,000 deaths in 2021 up 17% year-on-year, has made them even more indispensable.
An expert committee convened by the FDA voted in February to expand distribution of the nasal spray, agreeing on the extremely safe nature of the drug, harmless even if administered in error.
© 2023 AFP