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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Re-Files Abbreviated New Drug Application (ANDA) for KETAFREE™, Preservative-Free IV Ketamine
Globenewswire· 2025-09-29 12:03
KETAFREE™ to provide innovative, preservative-free IV ketamine formulation, eliminating toxic preservatives, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugsFiling is based on FDA interaction and approval of Suitability Petition for NRx’s proposed strength of preservative-free ketamineThis presentation of ketamine represents a reshoring of a strategically important drug to the US, in keeping with the Presidential Executive Order signed on May 5, 2025. Ketamine fac ...
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Receives Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine
Globenewswire· 2025-09-24 12:03
Suitability Petition is required for shift from multidose packaging of ketamine to single-patient dose preservative free ketamineGranting of Suitability Petition enables re-filing of Abbreviated New Drug Application (ANDA) for NRx’s patent-pending preservative-free ketamine product WILMINGTON, Del., Sept. 24, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a clinical-stage biopharmaceutical company, announced that it was notified yesterday by the United States Food and Drug Administration ...