Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
NRx Pharmaceuticals, Inc. announced on 06 April 2026, that it has received feedback from the Labeling Program within the U.S. Food and Drug Administration Office of Generic Drugs regarding the proposed label for its preservative-free ketamine product. The agency’s comments were limited to minor formatting revisions, and the company expects to submit the final label later this month.
Earlier, the U.S. Food and Drug Administration reported no bioequivalence deficiencies in NRx Pharmaceuticals, Inc.’s preservative-free ketamine ANDA, supporting continued regulatory review of the application.
NRx stated that its preservative-free ketamine product could help expand U.S. supply at a time when multiple suppliers have reported backorders. The company noted that the product is manufactured in the United States and aligns with efforts to strengthen domestic production of critical medicines.
According to NRx, ketamine has been identified by the FDA as a strategically important product, and a Commissioner’s National Priority Voucher was recently awarded for a new U.S. manufacturing source of ketamine drug ingredient.
Dr. Jonathan C. Javitt, CEO and Chairman of NRx, said the company appreciates the FDA’s timely review of the proposed labeling and expects continued collaboration with the agency as the application progresses.
In parallel, NRx reported that it is preparing a New Drug Application under Fast Track designation to expand the use of intravenous ketamine for patients with severe depression, including those with suicidal ideation.
Reference
NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Labeling Alignment for NRx’s Preservative-Free Ketamine Application, 06 April 2026, NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Labeling Alignment for NRx’s Preservative-Free Ketamine Application | Mon, 04/06/2026 – 07:00
About the Writer
Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.
