FDA aims to speed naloxone generics to market

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Kevron2001)
(Image: Getty/Kevron2001)

Related tags Teva Naloxone US FDA Opioid Opioid epidemic

US FDA follows up the first generic approval of naloxone nasal spray by encouraging companies to apply with generic applications amid the North American opioid crisis.

The on-going opioid crisis in the North America continues to develop as cases against several companies accused of playing a part in the crisis come to a head​.

Meanwhile, the US Food and Drug Administration (FDA) is still working on the regulatory side to mitigate the impact of opioid addiction, which resulted in 47,600 overdose deaths in 2017​. The opioid was suggested to be one of the significant reasons behind the reputation of pharma becoming the lowest ranking of industries in the US, according to Gallup research​.

As part of its strategy, the FDA announced that it would work to speed up the regulatory review of generic naloxone, in a statement​ released by FDA acting commissioner, Ned Sharpless.

The announcement revealed that the FDA would grant priority review to all generic applications for products that treat opioid overdose.

As a result, developers of such products would receive shorter timelines or earlier reviews on their applications, as well as increased communication and engagement with the agency.

In April 2019, Teva received the first approval​ for a generic naloxone nasal spray, which is used in cases of opioid overdose. The statement also revealed that the agency is looking to improve the availability of all forms of naloxone, which currently is available in three delivery forms: injectable, auto-injector, and nasal spray.

Barriers to access

In addition to encouraging the development of further generics, the FDA also outlined where there are potential barriers to access of overdose treatments for patients.

In the US, all current treatment options for opioid overdose need a prescription, which the agency admitted could prevent access.

However, as a result of the crisis, the agency observed that most states had passed laws allowing pharmacists to dispense naloxone under a standing order rather than requiring a prescription. Some states have also provided pharmacists with the ability to prescribe and sell naloxone directly consumers.

Despite these measures, the agency noted that many pharmacists are unaware of the existence of such standing orders and measures, making them unlikely to provide naloxone to those asking for the treatment.


In order to mitigate such issues, the FDA is aiming to make naloxone products available as over-the-counter (OTC) treatments, by working to develop labelling requirements proactively – marking the first time that the had developed a ‘drug facts label’ to support development of an OTC product.

The agency explained that “drug companies can use this information as part of an application to obtain approval for OTC naloxone.”

Further actions the FDA are looking at were revealed to be working with manufacturers to determine whether shelf-life extensions for naloxone products are possible, conducting additional research on the naloxone, and determining whether it would be possible to co-prescribe the treatment.

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