FDA Approves Preservative-Free Generic Ketamine as Shortage Drags On

The Food and Drug Administration has approved a preservative-free generic version of ketamine injection made for NRx Pharmaceuticals, the company announced on Oct. 30, adding a new U.S. supplier for an anesthesia drug that hospitals have struggled to keep in stock since 2018. The approval landed ahead of a Nov. 10 review goal date under the generic drug program, and the product will be manufactured by Nephron Pharmaceuticals in West Columbia, South Carolina.

Ketamine hydrochloride injection remains listed as "Currently in Shortage" in the FDA's drug shortage database, and the agency's entry does not give a date when the shortage is expected to end.

What the approval actually covers

NRx said the approval came through an abbreviated new drug application, the pathway used for generic copies of already-approved medicines. The company did not disclose the approved strengths or a launch date. It said commercial supply has already been manufactured and that it will proceed with labeling and shipping to American hospitals and clinics.

The product is packaged using blow-fill-seal equipment rather than traditional glass vials. NRx argues that switch will help relieve the glass-bottled ketamine shortage — a claim that will be tested by how much product reaches hospital pharmacies and how quickly, not by the approval itself.

"We are excited to bring Preservative-Free Ketamine to market," said Dr. Jonathan Javitt, NRx's chairman and chief executive, crediting Nephron with showing that "sterile, preservative-free injectables can be made in America."

A shortage first logged in 2018

The American Society of Health-System Pharmacists recorded the first ketamine injection shortage in February 2018. Its shortage listing, as republished by Drugs.com, describes backorders on certain vial sizes at several manufacturers, with increased demand, manufacturing delays and a shortage of the active ingredient cited as causes, while other makers report product available.

Supply has also contracted. In November 2025, Pfizer reported that it was discontinuing a 500-milligram multiple-dose glass vial of ketamine, according to a Drugs.com discontinuation listing.

Ketamine is not an isolated case. Active U.S. drug shortages rose to 227 in the second quarter of 2026, the third consecutive quarterly increase, according to ASHP and University of Utah figures reported by the trade publication AJMC.

The unapproved second life ketamine has in mental health

The approval covers anesthesia, not psychiatry. Ketamine injection is not FDA-approved to treat depression. Some clinics administer intravenous ketamine off-label for depression, and the only FDA-approved ketamine-related treatment for depression is the esketamine nasal spray Spravato, which is dispensed under a restricted safety program.

NRx is separately pursuing approval of a different intravenous product, NRX-100, for suicidal depression. That product has not been approved, and the new generic approval does not extend to mental health use. Ketamine also holds no FDA-approved indication for any substance use disorder, even though researchers have tested it in addiction treatment settings.

That distinction matters for patients reading about the approval as though it settled the status of ketamine therapy. The clinics offering infusions for mood disorders operate outside the label, and their supply comes through the same strained distribution chain that hospitals draw on.

Who feels the shortage first

Hospitals, surgery centers and emergency departments absorb most of the disruption. When supply tightens, pharmacy teams ration vials, switch vial sizes, or substitute another agent for a fracture repair, an emergency procedure or a scheduled surgery. Smaller and rural hospitals, which have less purchasing power, can have a harder time securing backordered drugs.

For patients, the practical advice is unchanged. People scheduled for surgery generally do not need to act, because anesthesia teams select drugs based on what is safe and available, and substitutions are routine during shortages. Anyone with questions can ask the anesthesia team before a procedure which medicines are planned and why. People receiving ketamine for depression at a clinic should not stop or alter treatment because of shortage news; they can ask their clinician whether supply changes could affect their schedule and what alternatives exist.

The next test is a delivery, not an announcement

Whether the approval changes anything for patients depends on whether the product reaches hospital shelves and whether the FDA eventually removes ketamine from its shortage list. The agency updates the database as manufacturers report supply, so the listing itself is the closest thing to a public scoreboard. NRx has not given a shipping date.

The other thread worth following is regulatory rather than commercial: the company's separate bid for an intravenous ketamine product aimed at suicidal depression, which would move ketamine from an off-label psychiatric experiment into a labeled indication if it succeeds. Nothing about the Oct. 30 approval shortens that path.

For now the shortage remains active, and hospitals will keep managing it case by case — the same way they have since 2018. People looking for treatment for opioid use disorder can find medication-assisted treatment programs and hospital-based care through the site's directories, and readers tracking mental health policy can start with our coverage of conditions treated alongside addiction. The FDA's earlier warning letters to online ketamine sellers document the other side of this market.