NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine
NRX Pharmaceuticals, Inc. (NRXP)
Company Research
Source: GlobeNewswire
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026.NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine.Current worldwide generic ketamine market is estimated at $750 million per year.NRx has manufactured initial registration lots of KETAFREE™ and is prepared to scale manufacturing to 1 million vials per month.NRx is awaiting a response to its Citizen Petition filed in August with the FDA seeking the removal of Benzethonium Chloride preservative from all forms of ketamine sold in the United States WILMINGTON, Del., Dec. 02, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that th
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NRXP
News
- NRx Pharmaceuticals (NASDAQ:NRXP) had its "buy" rating reaffirmed by analysts at BTIG Research. They now have a $25.00 price target on the stock.MarketBeat
- NRx Pharmaceuticals to discuss new NRX-101 pipeline indication for augmentation of Transcranial Magnetic StimulationGlobeNewswire
- NRx Pharmaceuticals (NRXP) Announces FDA Receipt of ANDA for KETAFREE With July 2026 Review Goal Date [Yahoo! Finance]Yahoo! Finance
- NRx Pharmaceuticals, Inc. (NRXP) Discusses Regulatory Update and Development Pipeline Expansion for Preservative-Free Ketamine Formulation Transcript [Seeking Alpha]Seeking Alpha
- NRx Pharmaceuticals (NASDAQ:NRXP) had its "buy" rating reaffirmed by analysts at D. Boral Capital. They now have a $34.00 price target on the stock.MarketBeat
NRXP
Earnings
- 11/14/25 - Miss
NRXP
Sec Filings
- 11/26/25 - Form 8-K
- 11/21/25 - Form 8-K/A
- 11/14/25 - Form 10-Q
- NRXP's page on the SEC website