NRx Pharmaceuticals announces FDA labeling alignment for ketamine product

NRx Pharmaceuticals (NRXP) announced that it has received a letter from the labeling program of the FDA Office of Generic Drugs whose only comments were limited to minor formatting changes to the proposed label for the company’s preservative-free ketamine product. The company expects to submit the final label this month. The determination is deemed preliminary until final supervisory review of NRx’s abbreviated new drug application with anticipated approval in Summer 2026. The company said this determination by FDA is meaningful in that NRx’s product has the potential to substantially augment the supply of US manufactured ketamine at a time when multiple suppliers of ketamine are advising the medical community that they are on backorder. In addition to the pending ANDA application for Preservative Free Ketamine, NRx is preparing a new drug application under fast track designation to expand the use of intravenous ketamine to treat patients with severe depression, who may have suicidal ideation.