NRx Pharmaceuticals receives FDA preliminary labeling approval for ketamine

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) announced it received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for its preservative-free ketamine product. The FDA's comments were limited to minor formatting changes to the proposed label.

The company expects to submit the final label this month. The determination remains preliminary until final supervisory review of NRx's Abbreviated New Drug Application, with anticipated approval in summer 2026 under the Generic Drug User Fee Act.

NRx previously received a preliminary determination of bioequivalence for this product. The preservative-free ketamine is manufactured in the United States at a time when multiple ketamine suppliers have advised the medical community they are on backorder.

"We deeply appreciate the FDA's timely review of the proposed labeling for our generic drug application and look forward to an ongoing collaborative relationship," said Dr. Jonathan C. Javitt, NRx's CEO and Chairman.

The FDA recently awarded a Commissioner's National Priority Voucher for a new US manufacturing source of ketamine drug ingredient, as the agency has deemed ketamine a highly strategic product.

NRx is also preparing a New Drug Application under Fast Track Designation to expand intravenous ketamine use for treating patients with severe depression who may have suicidal ideation.

The clinical-stage biopharmaceutical company develops therapeutics based on its NMDA platform for central nervous system disorders, including suicidal depression, chronic pain, and PTSD.

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