NRx Pharma Submits ANDA For Preservative-free IV Ketamine

(RTTNews) - NRx Pharmaceuticals, Inc. (NRXP), Thursday said it has submitted Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for preservative-free IV ketamine formulation, NRX-100, for all approved uses such as anesthesia and pain management.

NRx expects priority review from the FDA considering the current and anticipated drug shortage.

This filing supplements the New Drug Application for NRX-100 in suicidal depression with a PDUFA action date anticipated in late 2025.

The current annual ketamine market is estimated at $750 million with worldwide demand expected to increase to $3.35 billion by 2034.

The company anticipates filing a citizen's petition with the FDA to remove benzethonium chloride, a known neurotoxic and cytotoxic substance, from presentations of ketamine intended for intravenous use.