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# NRx Petitions FDA to Ban Preservative in Ketamine
- URL: https://www.fdaweb.com/nrx-petitions-fda-to-ban-preservative-in-ketamine/
- Published: 2025-09-09T12:00:00.000Z
- Updated: 2026-09-14T15:21:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159835

NRx Pharmaceuticals has petitioned FDA seeking a ban on all ketamine products formulated with the preservative benzethonium chloride, arguing that the substance poses unnecessary health and environmental risks. In the petition, the company says the preservative was included in early formulations of ketamine hydrochloride (marketed as Ketalar) in the 1970s under the mistaken belief it was necessary for multidose stability and sterility. While ketamine was originally approved as an anesthetic for occasional use, it is now widely prescribed in repeated doses for depression, post-traumatic stress disorder, and other mental health conditions, it says.

Benzethonium chloride, a quaternary amine compound, is no longer permitted by FDA even in hand sanitizers or antiseptic products due to its toxicity, according to the [petition](https://downloads.regulations.gov/FDA-2025-P-3577-0001/attachment%5F1.pdf?ref=fdaweb.com). It notes that related preservatives, such as benzalkonium chloride, have been linked to ocular and nerve damage in eye drops, while reports of interstitial cystitis have emerged among patients receiving repeated intravenous ketamine doses. By contrast, Janssen’s FDA-approved S-ketamine nasal spray, which contains no preservative, has not been associated with such issues, it adds.

The petition further argues that removing benzethonium chloride would not disrupt supply. NRx says it has already developed a preservative-free, single-use ketamine presentation manufactured in the U.S., filed data with FDA to support an ANDA, and can supply up to 10 million doses per month.