NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Gains FDA Nod for Preservative-Free Ketamine Suitability Petition
FDA grants NRx Pharmaceuticals approval of a Suitability Petition for single-patient preservative-free ketamine. The decision enables re-filing of an Abbreviated New Drug Application (“ANDA”) for the company’s KETAFREE(TM) product, which the company has now done. Current ketamine formulations use multidose vials with a toxic preservative, Benzethonium Chloride. U.S. ketamine market is estimated at $750 million annually, presenting a significant commercial opportunity. NRx is also advancing NRX-100 and NRX-101 for suicidal depression and PTSD, both with FDA designations. The move aligns with U.S. policy goals on reshoring drug production and reducing toxic additives. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company,…
