The approval is part of the FDA’s wider effort to make tools for stopping or preventing opioid overdoses more accessible and widely used. The agency is also working with drug companies to bring over-the-counter versions of naloxone to market, and is prioritizing the approval of other generic naloxone products.
Friday’s announcement, which makes official a tentative approval previously granted to Teva Pharmaceuticals, means there will soon be a generic alternative to Narcan, the widely used naloxone nasal spray sold by Emergent BioSolutions.
Naloxone can also be delivered by injection. Generic versions of injectable naloxone have been available for years, and can cost as little as $20 to $40. Nasal sprays, however, provide a more user-friendly delivery vehicle that can be used even by those without medical training, such as civilians and loved ones of those struggling with substance use, as well as first responders.
Nearly 50,000 Americans died from an opioid overdose in 2017, according to federal estimates. Heroin and prescription opioids continue to contribute to many deaths, but potent synthetic opioids such as fentanyl have become a rapidly growing problem in recent years, according to federal data.
The list price for a Narcan kit is set at $125, though Emergent runs several programs meant to make Narcan more affordable and accessible for first responders, government agencies and others who need it. Last year, the company offered to distribute Narcan to every public library and YMCA in the country. Narcan can also now be purchased at many major pharmacies, and — although it is not technically an over-the-counter product — state orders often allow it to be purchased without a prescription.
A Teva representative told TIME that details about the generic version’s pricing and release are not yet available.