NRx Pharmaceuticals Files for FDA Commissioner's National Priority Voucher for Innovative Ketamine Formulation, Anticipates Approval Decision by Year-End 2025

Reuters
06-23
NRx Pharmaceuticals Files for FDA Commissioner's National Priority Voucher for Innovative Ketamine Formulation, Anticipates Approval Decision by Year-End 2025

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CL15658) on June 23, 2025, and is solely responsible for the information contained therein.

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