FDA approves NRx preservative-free ketamine injection
The U.S. Food and Drug Administration approved NRx Pharmaceuticals’ abbreviated application for a ketamine injection that excludes benzethonium chloride. The decision arrived before the agency’s November 10 target date. NRx says the U.S.-made product is intended for hospital and clinic use amid an ongoing ketamine shortage, with manufacturing support from Nephron Pharmaceuticals.
Why it matters
The approval gives NRx a cleared product that it can move toward supplying to U.S. hospitals and clinics, subject to commercial execution. The company says the formulation could help address the shortage of injectable ketamine and replace products containing benzethonium chloride.
Key facts
- 1FDA approved NRx Pharmaceuticals’ Abbreviated New Drug Application for Preservative-Free Ketamine before the November 10, 2026 goal date. stocktitan.net
- 2The approved formulation contains no benzethonium chloride, while NRx stated that all currently available ketamine injections contain the preservative. stocktitan.net
- 3NRx is manufacturing the injectable product in the United States with Nephron Pharmaceuticals in West Columbia, South Carolina. stocktitan.net
- 4NRx said ketamine injection has been in short supply since 2018. stocktitan.net
Summary written by AlphAI AI Desk from 8 of 8 sources. Not investment advice. Figures are as stated by the linked sources.