FDA Approves NRx’s Preservative-Free Ketamine Application Ahead of Target Date

Key Facts

NRx Pharmaceuticals said the U.S. Food and Drug Administration approved its abbreviated ANDA for a preservative-free ketamine formulation ahead of the regulatory target date of November 10. The decision allows the company to move to preparing the product for commercial supply, as it said it already has manufactured supplies. CEO Jonathan Javitt said: "With commercial manufactured supply available, we can now label our product and supply it to U.S. hospitals and clinics." The company says ketamine injections have faced supply shortages since 2018 and are currently listed on the FDA’s drug-shortage list. In available EL7 data, NRXP closed at $2.66 on October 29, compared with a close of $2.69 on October 28; these prices do not establish a share-price jump on October 29.

The approval covers an ANDA for a preservative-free ketamine formulation and does not mean approval of a new drug to treat depression or suicidality. NRx says the formulation does not contain benzethonium chloride, known by the abbreviation BZT, and will be manufactured in the United States in collaboration with Nephron Pharmaceuticals. The manufacturing site is in West Columbia, South Carolina, and uses blow-fill-seal technology. The company explains that ketamine is used primarily for anesthesia and pain relief, including during labor and delivery. The announced approval therefore focuses on a formulation for established uses, while the development of other therapeutic claims remains separate.

The company links the importance of bringing the product to market to the ketamine injection shortage it says has continued since 2018, and to the product’s inclusion on the FDA’s shortage list. Its statement says some manufacturers have stopped production, while the company said its manufactured commercial inventory now allows it to label and supply the product to U.S. hospitals and clinics. The FDA says drug shortages can arise from manufacturing and quality problems, delays or production discontinuations. The agency also says it works with manufacturers to prevent or mitigate supply disruptions. This context places NRx’s move in a market the company says faces a continuing shortage, without the announcement specifying the inventory volume or supply schedule.

Alongside the ANDA track, NRx is seeking a new approval for the intravenous ketamine formulation NRX-100 with claims to treat depression and suicidality. This application is separate from the formulation that received approval, and that ANDA approval does not grant those therapeutic uses. In March, the company said the FDA had indicated it was willing to review data from existing clinical trials alongside real-world evidence to support the NRX-100 application, and that the agency had not requested additional clinical trials. The company had said it intended to submit the new drug application by June 2026. It also announced a call to discuss the approval on October 30, 2026, at 8:30 a.m. Eastern time; the available facts did not include the call’s outcome or a subsequent update on the submission of the NRX-100 application.