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NRx Pharmaceuticals Announces Filing Of Commissioner's National Priority Voucher Application For Intravenous Ketamine

Benzinga·06/23/2025 12:15:50
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  • Company has applied for new Commissioner's National Priority Vouchers (CNPV) for NRX-100. Continues to anticipate decisions on drug approval by year-end 2025



     
  • Application under CNPV program is accretive to already-filed Abbreviated New Drug Application (ANDA) for preservative-free ketamine, with proprietary formulation under priority review request



     
  • Company has received and complied with FDA information request for updated drug ingredient and label information on NRX-100



     
  • Company has previously filed full Chemical Manufacturing and Controls (CMC) information for NRX-100 with FDA and has reported stability and sterility data sufficient to anticipate three-year room temperature shelf life for preservative-free ketamine