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Posted by
Two Blokes Jun 23 -
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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 WILMINGTON, Del.
