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NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application
Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA).FDA has advised NRx in
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA).FDA has advised NRx in written correspondence that it has not identified any bioequivalence deficiencies in the Company’s Preservative-Free Ketamine product. This communication is deemed preliminary until final supervisory review.NRx continues to anticipate an FDA GDUFA decision on its ANDA application in Summer 2026 as previously announced.The ANDA process is focused on offering a preservative-free alternative in the existing ketamine market through the FDA Office of Generic Drugs and is separate from NRx’s path to a New Drug Application to use ketamine in the treatment of depression, being pursued through the FDA Division of Psychiatry Products. WILMINGTON, Del., March 17, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has received a letter from the Bioequivalence Program of the FDA Office of Generic Drugs stating that “FDA has not identified any bioequivalence deficiencies at this time.” The determination is deemed preliminary until final supervisory review of NRx’s Abbreviated New Drug Application with anticipated approval in Summer 2026. This determination by FDA is meaningful in that the proposed NRx product is the first ketamine formulation to be free of benzethonium chloride (BZT), a known toxic preservative. Benzethonium chloride is not listed by FDA as Generally Recognized as Safe (GRAS) and is no longer permitted in certain topical consumer applications. Ketamine formulations containing BZT date back to an era when the safety profile of quaternary amine preservatives was less well characterized.Prior to NRx’s preservative-free formulation, it was widely believed that BZT was required to maintain room temperature stability and sterility of ketamine. The Company anticipates demonstrating three years of room temperature stability and sterility for its preservative-free product. NRx has filed patents in the US and Internationally to support its preservative-free formulation and has the potential to create a “branded generic” product. NRx’s preservative free product is manufactured in the United States at a time when the FDA has identified ketamine as a strategically important medication and has emphasized...