From Nasdaq: 2025-06-05 09:03:00

NRx Pharmaceuticals, Inc. has submitted an ANDA to the FDA for preservative-free IV ketamine formulation, NRX-100, for anesthesia and pain management. They expect priority review due to a drug shortage. The company also filed for NRX-100 in suicidal depression, with a PDUFA action date in late 2025. The annual ketamine market is worth $750 million, projected to reach $3.35 billion by 2034. NRx plans to file a citizen’s petition to remove benzethonium chloride from ketamine intended for IV use, citing its neurotoxic and cytotoxic properties.



Read more at Nasdaq: NRx Pharma Submits ANDA For Preservative-free IV Ketamine