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# FDA Asks ‘Minor’ Labeling Changes for NRx Ketamine
- URL: https://www.fdaweb.com/fda-asks-minor-labeling-changes-for-nrx-ketamine/
- Published: 2026-10-15T15:36:53.000Z
- Updated: 2026-10-15T15:36:53.000Z
- Author: David McFarland

FDA has asked NRx Pharmaceuticals to submit “minor” changes to the submitted label for the company’s preservative-free ketamine product NRX-100\. A company [statement](https://www.biospace.com/press-releases/nrx-pharmaceuticals-announces-receipt-of-fda-labeling-review-letter-for-preservative-free-ketamine?ref=fdaweb.com) says NRx was asked to submit sample labeling with the proposed proprietary name currently under review in advance of the 11/10 GDUFA target action date. The statement says NRX-100 has been awarded Fast Track designation for treating suicidal ideation in depression, including bipolar depression.