Treats known or suspected opioid overdose. NDA 208969, held by Amphastar Pharms Inc. Naloxone Hydrochloride.
As of Nov 13, 2026, NDA 208969 (Rextovy), held by Amphastar Pharms Inc, was first approved by FDA on Mar 7, 2023, with 2 approved supplements and 1 published complete response letter.
REXTOVY Nasal Spray is indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. REXTOVY Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REXTOVY Nasal Spray is not a substitute for emergency medical care. REXTOVY Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adults and pediatric patients.
| Jun 16, 2026 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 7, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Feb 17, 2017 | NaloxoneFacility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rextovy4MG/SPRAY · spray, metered;nasal | Naloxone Hydrochloride | DiscontinuedReference drug |
| Jun 16, 2026 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Mar 7, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
