other_material
confidence high
sentiment positive
materiality 0.65
NRx Pharma files ANDA for preservative-free IV ketamine; market at $750M
NRX Pharmaceuticals, Inc.
- Filed ANDA for NRX-100 (preservative-free IV ketamine) with FDA; seeks priority review due to drug shortage.
- Ketamine market currently $750M, projected to reach $3.35B globally by 2034.
- Plans citizen petition to remove benzethonium chloride from all IV ketamine products.
- Complements ongoing NDA for suicidal depression; PDUFA target late 2025; FDA waived $4.3M fee.
- Patent protection sought through 2045; Fast Track designation previously granted.
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