NRx Pharmaceuticals announced that it has 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, with the determination deemed preliminary until final supervisory review of NRx’s Abbreviated New Drug Application with anticipated approval in Summer 2026.
The determination is significant because NRx’s preservative-free ketamine product has the potential to substantially augment the supply of U.S. manufactured ketamine at a time when multiple suppliers of ketamine are advising the medical community that they are on backorder. NRx’s preservative-free product is manufactured in the United States at a time when the FDA has deemed ketamine to be a highly strategic product and recently awarded a Commissioner’s National Priority Voucher for a new U.S. manufacturing source of ketamine drug ingredient.
Expanded Ketamine Applications
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. NRX-100, the preservative-free intravenous ketamine product, has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression. NRX-101, an oral formulation of D-cycloserine/lurasidone, has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1110946390/Nrx-Pharmaceuticals-NasdaqNRXP-Announces-FDA-Labeling-Alignment-For-Nrxs-Preservative-Free-Ketamine-Application