FDA Approves NRx's Generic Ketamine, But Its Bid to Ban Rivals' Products Is Still Pending
Psychedelic Alpha's Noah Smith and Josh Hardman report that the FDA has approved NRx Pharmaceuticals' generic, preservative-free ketamine, branded KETAFREE — about three months later than the company expected, and on-label only for anesthesia, the same indication as the branded product it copies, Ketalar. NRx developed it with Nephron Pharmaceuticals, which handles fill-and-finish manufacturing in South Carolina.
The approval is step one of a two-part strategy the outlet has been tracking since early 2025. Step two, still pending, is a citizen petition NRx filed with the FDA in September 2025 asking it to ban ketamine products that use the preservative benzethonium chloride (BZT) — which would force most of the rest of the U.S. ketamine market, including Ketalar as currently made, off the shelf. Psychedelic Alpha's own reporting is skeptical of the safety case behind that ask: it finds NRx's supporting toxicology report models anesthesia and ICU-level dosing rather than psychiatric dosing, contains internal inconsistencies, and leaves out a study that found BZT didn't reach mice's brains. The outlet also notes NRx has had to narrow an earlier "first preservative-free ketamine" claim, since Baxter received FDA approval for its own preservative-free ketamine syringe in September 2025 and again in August 2026.
Per the outlet, Chairman and Chief Scientist Jonathan Javitt says NRx will price KETAFREE in line with the market and holds no exclusivity on it. The approval doesn't touch the psychiatric side of the ketamine market: Spravato remains the only ketamine-derived product approved for a psychiatric indication, and NRx's separate push for an on-label psychiatric ketamine product, NRX-100, is a distinct program still working through the FDA. We looked at how thin the commercial patent protection around ketamine actually is in our deep dive on the ketamine patent gap — this is a live example of a generic challenger trying to use a citizen petition, not a patent fight, to clear the field.