Treats known or suspected opioid overdose induced by natural or synthetic opioids. NDA 218590, held by Knoa Pharma. Nalmefene Hydrochloride.
As of Nov 14, 2026, NDA 218590 (Zurnai (Autoinjector)), held by Knoa Pharma, was first approved by FDA on Aug 7, 2024, with 0 approved supplements and 0 published complete response letters.
ZURNAI is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. ZURNAI is intended for immediate administration as emergency therapy in settings where opioids may be present. ZURNAI is not a substitute for emergency medical care.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2024 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zurnai (Autoinjector)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML) · solution;intramuscular, subcutaneous | Nalmefene Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
