Information on Naloxone Auto-injector (marketed as Evzio)
FDA approved Evzio (naloxone hydrochloride injection), a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector.
Evzio is the first auto-injector designed to deliver a dose of naloxone outside of a health care setting.
- FDA approves new hand-held auto-injector to reverse opioid overdose FDA news release
- FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse
- Opioid Auto-Injector Can Help Prevent Overdose Deaths FDA Voice blog
- Evzio Label
- Summary Review for Regulatory Action for Evzio
- Approval letter to Evzio manufacturer, Kaleo Inc.