NRx Pharma FDA reclassifies ketamine ANDA amendment as minor
NRx Pharmaceuticals said the FDA moved its preservative-free ketamine (NRX-100) ANDA amendment from major to minor and set a GDUFA goal date of Nov. 10, 2026, adding it will not require substantial FDA resources.
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07:13:06 PM UTC
SquawkNews
NRx Pharmaceuticals said the FDA reclassified its preservative-free ketamine (NRX-100) ANDA amendment from major to minor and set a GDUFA goal date of Nov. 10, 2026, noting it will not require substantial FDA resources.Material DetailsContext by AI AnalystThis refines the regulatory path for NRX-10…
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