FDA Approves Preservative-Free Generic Ketamine

NRx Pharmaceuticals' ketamine clears the FDA ahead of its November 10 goal date, as the injectable has been in shortage since 2018.

Updated on Nov. 3, 2026 in Nursing Jobs

Photograph of a row of plain unlabeled glass vials in a stainless steel tray in a clean pharmaceutical cleanroom. — NRx Pharmaceuticals won FDA approval for its preservative-free generic ketamine injection ahead of a November 10 goal date, easing a shortage in place since 2018. AI Illustration. Upload story photo >

The FDA approved NRx Pharmaceuticals' preservative-free generic ketamine ahead of its announced November 10 goal date. The product addresses a shortage of ketamine injection that has persisted since 2018.

Why it matters

Ketamine is used primarily for anesthesia and pain control, including in labor and delivery, and currently appears on the FDA drug shortage list. The Secretary of Health and the FDA Commissioner identified ketamine as a strategic drug whose supply must be assured.

The approval came ahead of the FDA-announced November 10 goal date, ending a supply gap that has run since 2018 for the injectable. All currently available ketamine injection products contain benzethonium chloride, and the FDA has declined to designate that preservative as GRAS.

The players

NRx Pharmaceuticals

NRx Pharmaceuticals is a drug developer that obtained FDA approval for a preservative-free generic ketamine and filed a Citizen Petition seeking removal of benzethonium chloride from the drug.

U.S. Food and Drug Administration

The U.S. Food and Drug Administration is the federal agency responsible for approving drugs and maintaining the national drug shortage list, and it granted this approval through its Office of Generic Drugs.

Nephron Pharmaceuticals

Nephron Pharmaceuticals is a West Columbia, S.C.-based manufacturer and NRx's partner in producing the preservative-free ketamine.

The details

NRx Pharmaceuticals manufactured the preservative-free ketamine with partner Nephron Pharmaceuticals in West Columbia, S.C., and the approval was granted by the FDA Office of Generic Drugs. Alongside the approval, NRx filed a Citizen Petition asking FDA to remove benzethonium chloride from ketamine, and an expert toxicology report is available on the FDA docket.

Since 2018: Ketamine injection shortage began.
1970: Ketamine was initially formulated to contain benzethonium chloride.
November 10, 2026: FDA-announced approval goal date, which the approval beat.

Market Landscape

Ketamine injection has been on the FDA drug shortage list, and the Secretary of Health and FDA Commissioner have treated it as a strategic drug. This approval adds a preservative-free generic supplier to a market where every currently available injectable contains benzethonium chloride.

Hospitals and clinics that rely on ketamine for anesthesia and pain control may gain a preservative-free option once the product is labeled and supplied. The change matters most for patients and clinicians whose care depends on injectable ketamine being available.

The takeaway

A restored supply of injectable ketamine could ease pressure on hospitals that have managed a shortage since 2018. Readers tracking drug availability can watch for the product's labeling and distribution as NRx begins supplying American facilities.