Treats known or suspected overdose induced by natural or synthetic opioids. NDA 217470, held by Indivior. Nalmefene Hydrochloride.
As of Nov 13, 2026, NDA 217470 (Opvee), held by Indivior, was first approved by FDA on May 22, 2023, with 0 approved supplements and 0 published complete response letters.
OPVEE nasal spray is indicated for the emergency treatment of known or suspected 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. OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. OPVEE nasal spray is not a substitute for emergency medical care.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2023 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OpveeEQ 2.7MG BASE/SPRAY · spray;nasal | 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
