NRx Pharmaceuticals Inc. (NASDAQ: NRXP) received a positive review letter from the FDA Office of Generic Drugs regarding its preservative-free ketamine application, according to a company statement.

The Discipline Review Letter covering drug quality requested only minor administrative changes and updates to prior stability data. The review addressed drug substance, drug product, manufacturing, and microbiology aspects of the application.

The company held a meeting with FDA Office of Generic Drugs leadership, where officials expressed support for addressing remaining application aspects within the current review cycle targeting approval in summer 2026. This follows a favorable bioequivalence determination the company received from the FDA on March 17, 2026.

NRx's ketamine formulation differs from existing products by excluding benzethonium chloride, a preservative the company states is no longer permitted in new drugs under FDA policy.

The company cited a presidential executive order from April 16, 2026, directing expedited approval for drugs treating severe depression, suicidality, and PTSD. The U.S. Department of Veterans Affairs has identified ketamine as medically necessary for treating suicidality and treatment-resistant depression.

"Every 11 minutes an American dies from suicide. Every day we lose 20 or more Veterans and Soldiers, along with countless first responders," said Dr. Jonathan C. Javitt, NRx's CEO and Chairman.

NRx is also preparing a New Drug Application to align ketamine labeling with its use in treating depression and suicidality. The company develops treatments for central nervous system disorders including suicidal depression, chronic pain, and PTSD.