NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, has announced its filing for the newly-introduced FDA Commissioner's National Priority Voucher (CNPV) program for NRX-100, a patent-pending, preservative-free formulation of ketamine for intravenous use. This filing is part of their ongoing regulatory review, with the company anticipating decisions on drug approval by the end of 2025. NRX-100 is aimed at addressing unmet medical needs, particularly in the treatment of suicidal depression and PTSD. The company has previously submitted the chemistry, manufacturing, and controls $(CMC)$ portion of the application, receiving FDA feedback, and has complied with requests for updated drug ingredient and label information. This CNPV application complements their Abbreviated New Drug Application (ANDA) for the same formulation, which is under priority review.
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