NRx Pharmaceuticals has received a positive Discipline Review Letter from the FDA Office of Generic Drugs and completed a supportive meeting with Generic Drug Leadership, marking progress toward approval of its preservative-free ketamine program. The Discipline Review Letter covering drug substance, drug product, manufacturing, and microbiology requests only administrative changes and updates to prior stability data, all identified as “Minor.”
FDA Support and Supply Needs
The positive review letter follows a previously announced favorable bioequivalence determination from the FDA Office of Generic Drugs on March 17. NRx additionally conducted a meeting with leadership of the FDA Office of Generic Drugs in which the national priority around expediting approval of ketamine was recognized, as documented in the President’s April 16 Executive Order on “Accelerating Medical Treatments for Serious Mental Illness.” FDA leadership expressed support for addressing the remaining aspects of the current ANDA application within the current review cycle targeting approval in Summer 2026.
Formulation Advantages
NRx’s presentation of ketamine differs from existing products in that it does not contain Benzethonium Chloride, a known toxic preservative that is no longer allowed to be included in new drugs and according to FDA policy cannot even be included in hand cleansers and topical antiseptics. Ketamine is identified as medically necessary by the US Department of Veterans Affairs for the treatment of suicidality and treatment-resistant depression. The approval of the preservative-free ketamine ANDA is particularly important because of supply shortages documented by physicians who seek to obtain ketamine for use in the clinic setting.
CEO Dr. Jonathan C. Javitt said “Every 11 minutes an American dies from suicide. Every day we lose 20 or more Veterans and Soldiers, along with countless first responders. We are committed to working with FDA to bring lifesaving treatments to patients who need them.”
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/nrx-pharmaceuticals-reports-positive-fda-office-of-generic-drugs-feedback-on-preservative-free-ketamine-program