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NRx Pharmaceuticals (NRXP) Announces FDA Receipt of ANDA for KETAFREE With July 2026 Review Goal Date
LOS ANGELES, CA - December 2, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said the FDA has received its Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketam...
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"LOS ANGELES, CA - December 2, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said the FDA has received its Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation, deeming the submission "substantially complete" and assigning a July 29, 2026 review goal date. CEO Jonathan Javitt said KETAFREE is designed to provide a single-patient, preservative-free alternative to current multidose ketamine vials that contain Benzethonium Chloride, a compound no longer recognized as safe by the FDA. The Company said KETAFREE aligns with MAHA initiatives to remove toxic substances from medicines and supports domestic supply-chain priorities, with potential 2026 approved drug sales if approved on schedule. NRx noted the program is separate from NRX-100, its Fast Track-designated treatment for suicidal depression, and said it continues to advance its broader pipeline and HOPE Therapeutics clinics.","length":1004,"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/OaRPK","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...