NRx Pharmaceuticals announced that it received preliminary FDA alignment on labeling for its preservative-free ketamine product. The Labeling Program of the FDA Office of Generic Drugs indicated that its 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 FDA’s determination is meaningful 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 are on backorder. NRx’s preservative-free product is manufactured in the United States 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, reflecting a key administration focus on “re-shoring” critical elements of the U.S. drug supply.
Dual Development Pathway
NRx previously received a preliminary determination of bioequivalence for the preservative-free ketamine product. In addition to the pending ANDA application, NRx is 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. NRX-100 has been awarded Fast Track Designation for suicidal ideation in depression, including bipolar depression, while NRX-101, an oral D-cycloserine/lurasidone combination, has been awarded Breakthrough Therapy Designation for suicidal bipolar depression.
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-nasdaq-nrxp-announces-fda-labeling-alignment-for-nrxs-preservative-free-ketamine-application