NRx Pharmaceuticals receives FDA bioequivalence determination for ketamine

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NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application

March 17, 2026 7:00 AM EDT

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 Companys 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... More