A Company Asked the FDA to Ban Most Ketamine. The Public Docket Has Two Comments
A drug company has asked the Food and Drug Administration to ban ketamine products made with a common preservative. The same company sells a version without it, and expects an approval decision in early November. The request surfaced in a New York Times report on Monday. The petition is public, the docket is still open, and two comments have been filed on it in thirteen months.
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| Key Takeaway | Detail |
|---|---|
| The filing | Citizen Petition from NRx Pharmaceuticals, docket FDA-2025-P-3577, received September 4, 2025 |
| What it asks | That FDA ban all products containing ketamine combined with benzethonium chloride |
| Who benefits | NRx is awaiting approval for Ketafree, a preservative-free ketamine |
| The evidence | NRx’s chief executive acknowledged to the Times there is no human data tying the preservative to harm |
| Comments filed | Two have been published since the docket opened |
| Status | Open, and marked as allowing late comments |
What the Petition Actually Asks For
The docket title is not ambiguous. It reads, requests that the FDA ban all products containing ketamine combined with benzethonium chloride.
Benzethonium chloride, or BZT, is a preservative. The Times reports that virtually all ketamine contains it, which is what gives the request its reach.
It was received on September 4 last year and posted the following day. The agency’s drug evaluation center has it docketed as a citizen petition.
The Company Asking Also Sells the Alternative
NRx Pharmaceuticals filed the petition. NRx is also seeking approval for Ketafree. That is generic ketamine in a vial that stays sterile without a preservative.
So one filing would remove the existing supply from the market. The other would put the company’s own product in its place.
The Times reports NRx has already ordered five million doses ahead of a decision. Executives would not say what they plan to charge.
What the Evidence Looks Like
NRx chief executive Jonathan Javitt addressed the evidence directly. He acknowledged the lack of data tying the preservative in ketamine to harm in humans.
His argument rests on precedent elsewhere. FDA barred the compound from over-the-counter hand sanitizers in 2019, and manufacturers phased it out of most eye products.
Critics in the piece make the opposite case. The preservative has been in medicines for more than half a century without reported problems.
Christian Yavorsky worked on the trials behind Spravato. He said patients do not receive enough doses for the preservative to cause harm. A board member of the American Society of Ketamine Physicians called the effort, in his words, unethical and cash-grabby.
Two Comments in Thirteen Months
We went to the docket to see what the field had said. The answer is almost nothing.
Two comments have been published since it opened. One is anonymous. The other came from a law firm acting for another company. It runs to seven attachments, including the brand ketamine label and the FDA order NRx cites.
That is the entire published record. The industry behind it runs to roughly 1,600 ketamine clinics, by our own directory count.
One company has made its case in detail. The providers who would absorb the consequences have not.
What a Ban Would Cost a Clinic
Generic ketamine costs roughly a dollar a dose. That is the number a ban would replace with an unknown one.
The Times puts the ketamine market at about $750 million. It notes the drug is made mostly in China and India, with shortages already intermittent.
That supply chain is already thin. Removing the dominant formulation from it is not the same as adding a competitor to it.
Nothing here is decided. A citizen petition is a request, and FDA can deny it. But the cost side of a clinic is a bad thing to learn about late. It is the same reason we keep a running calendar of regulatory deadlines.
The Window Is Still Open
The docket status reads open, and it is marked as allowing late comments.
Anyone can file one. It takes a form on the federal docket, and the comment becomes part of the public record the agency reviews.
A clinician buys this drug every week. That person knows things about handling, dosing and shortages that a sponsor’s petition does not contain.
The docket is FDA-2025-P-3577, and comments go through the comment form on that petition.
A Decision Measured in Weeks
NRx told the Times it expects a decision on Ketafree in early November. The petition sits on its own track, and FDA does not discuss pending applications.
What is certain is the timing. Both items are live now, and the comment record is two entries long.
Clinics comparing notes can start with our directory of verified ketamine clinics.
This article is for informational purposes and is not legal or medical advice. Petition and docket details come from the public record on regulations.gov, read October 21, 2026. Statements from company executives and clinicians are as reported by the New York Times.
