NRx Pharmaceuticals Receives FDA Letter Regarding Comments On Minor Formatting Changes To Proposed Label For Its Preservative-Free Ketamine Product, The Company Expects To Submit Final Label In April
Benzinga Newsdesk 7 months ago
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NRx has received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for NRx's preservative-free ketamine product. Labeling remains subject to final supervisory review.NRx
- NRx has received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for NRx's preservative-free ketamine product. Labeling remains subject to final supervisory review.
- NRx previously received a preliminary determination of bioequivalence for this product.
- The Company continues to anticipate a decision on approval under the Generic Drug User Fee Act (GDUFA) in Summer 2026.