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NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Labeling Alignment for NRx's Preservative-Free Ketamine Application [Yahoo! Finance]

NRX Pharmaceuticals, Inc. (NRXP) 
Company Research Source: Yahoo! Finance
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. WILMINGTON, Del., April 06, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has received a letter from the Labeling Program of the FDA Office of Generic Drugs whose only comments were limited to minor formatting changes to the proposed label for the Company's preservative-free ketamine product. The Company expects to submit the final label this month. The determination is deemed preliminary until final supervisory review of NRx's Abbreviated New Drug Application with anticipated approval in Summer 2026. This determination by FDA is meaningful in that NRx's product has the potential to substantially augment the supply of US manufactured Show less Read more
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