FDA finds no bioequivalence deficiencies in NRX Pharmaceuticals’ preservative-free ketamine ANDA review

Reuters03-17

FDA finds no bioequivalence deficiencies in NRX Pharmaceuticals’ preservative-free ketamine ANDA review

NRx said the FDA Office of Generic Drugs’ Bioequivalence Program informed the company in writing that it has not identified any bioequivalence deficiencies at this time for NRx’s preservative-free ketamine ANDA, subject to final supervisory review. NRx continues to expect an FDA GDUFA decision on the ANDA in Summer 2026. The company said its preservative-free ketamine formulation is intended to be free of benzethonium chloride and is expected to demonstrate three years of room-temperature stability and sterility.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603170700PRIMZONEFULLFEED9673416) on March 17, 2026, and is solely responsible for the information contained therein.

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