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NRx Pharmaceuticals (NRXP) Receives FDA Approval of Suitability Petition for Preservative-Free Ketamine Product
LOS ANGELES, CA - September 24, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted its Suitability Petition for KETAFREE(TM), a planne...
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"LOS ANGELES, CA - September 24, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted its Suitability Petition for KETAFREE(TM), a planned single-patient, preservative-free ketamine product. Unlike current ketamine offerings in multi-dose vials containing the toxic preservative Benzethonium Chloride, KETAFREE(TM) is designed to eliminate such additives. The approval enables immediate re-filing of the Company's Abbreviated New Drug Application. NRx noted the product supports federal priorities of re-shoring sterile drug manufacturing and removing harmful preservatives, with the ketamine market estimated at $750 million. The Company is also advancing NRX-100, a non-generic ketamine formulation under development for suicidal depression and PTSD.","length":869,"tagName":"p"},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":"Investor Brand Network","className":"","disableSlideshowImg":false,"size":{"original":{"width":610,"height":520,"url":"https://media.zenfs.com/en/newsmediawire_165/d8af5ae9288c0f70ceb08aa9713a28cf"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/kpD0NvVnaK_aNpdu.cQQ2w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTgxODtjZj13ZWJw/https://media.zenfs.com/en/newsmediawire_165/d8af5ae9288c0f70ceb08aa9713a28cf","width":610,"height":520}}},{"type":"text","content":"To view the full press release, visit https://ibn.fm/nqA1A","length":58,"tagName":"p"},{"type":"text","content":"About NRx Pharmaceuticals, Inc.","length":31,"tagName":"p"},{"type":"text","content":"NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal Ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for N...