NRx Pharmaceuticals Announces Receipt of FDA Labeling Review Letter for Preservative-Free Ketamine
NRx Pharmaceuticals received a FDA Discipline Review Letter for its Preservative-Free Ketamine ANDA, with all requested label changes classified as MINOR. The agency asked the company to submit sample labeling with the proposed proprietary name ahead of the November 10, 2026 GDUFA goal date.
Key figures
- Drug Name
- Preservative-Free Ketamine (NRX-100)
- Gdufa goal date
- November 10, 2026
- Change classification
- MINOR
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