NRx Pharma wins FDA approval of preservative-free ketamine ANDA, ahead of Nov 10 GDUFA goal date

NRX Pharmaceuticals, Inc.

FDA approved NRx's ANDA for Preservative-Free Ketamine ahead of the Nov 10, 2026 GDUFA goal date; CEO Javitt says commercial supply is on hand for labeling now.
Product is U.S.-manufactured with Nephron Pharmaceuticals in West Columbia, South Carolina, using blow-fill-seal technology and contains no benzethonium chloride (BZT).
NRx says all currently marketed ketamine injections contain BZT, which FDA has declined to designate GRAS; NRx filed a Citizen Petition seeking BZT's removal from ketamine.
Ketamine injection has been in short supply since 2018 and is on FDA's shortage list, with some manufacturers discontinuing production, per the release.
No pricing, financial terms, or revenue guidance were disclosed; company hosted a call at 8:30 a.m. ET on October 30, 2026.

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