The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Evzio (naloxone HCl injection; kaleo) 2mg.  

The application proposed a new 2mg dosage strength for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, and for immediate administration as emergency therapy in settings where opioids may be present. This NDA was originally submitted as a supplemental NDA (sNDA) but was administratively converted to an NDA.  

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Evzio, an opioid antagonist, will be available as two 2mg/0.4mL auto-injectors and a single Trainer. Evzio was originally approved as a 0.4mg/0.4mL strength auto-injector in 2014 and was the first naloxone product approved for family member or caregiver use. The product incorporates audio and visual cues to help the user through the injection process.

Naloxone HCl is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone HCl reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Also, it can reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine. 

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