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# FDA Approves Amphastar Naloxone Nasal Spray
- URL: https://www.fdaweb.com/fda-approves-amphastar-naloxone-nasal-spray/
- Published: 2023-03-09T12:00:00.000Z
- Updated: 2026-09-14T18:18:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153946

FDA has approved an Amphastar NDA for naloxone hydrochloride nasal spray 4mg, which is delivered using the company’s proprietary nasal delivery device. A company [statement](https://ir.amphastar.com/websites/amphastar/English/2110/news-detail.html?airportNewsID=fd568d0c-36f7-43b9-a888-87c8afa3e096&ref=fdaweb.com) says the naloxone spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adult and pediatric patients.