Nrx Pharmaceuticals Announces US Food And Drug Administration (FDA) Receipt Of ANDA For KETAFREETM, A Preservative-Free IV Ketamine. <li /> FDA has determined that NRx's Abbreviated New Drug Application (ANDA) is“substantially complete” and received for review.

Granting of Suitability Petition enables re-filing of Abbreviated New Drug Application (ANDA) for NRx's patent-pending preservative-free ketamine product NEW YORK, NY / ACCESS Newswire / September 24, 2025 / NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a ...

In June 2025 NRx filed an Abbreviated New Drug Application with the FDA for a preservative-free preparation of ketamine, demonstrating support for 3 year room temperature stability and sterility. NRx has similarly filed a patent on its preservative-free ...

MIAMI, April 30, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc., (Nasdaq:NRXP or "the Company"), today announced the grant of a filing fee waiver by the US Food and Drug Administration ("FDA") to exempt the Company from a $4.3 million fee to file its New ...

WILMINGTON, Del., June 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and ...

NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine.

Granting of Suitability Petition enables re-filing of Abbreviated New Drug Application (ANDA) for NRx’s patent-pending preservative-free ketamine product NEW YORK, NY / ACCESS Newswire / September 24, 2025 / NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a ...