NRx receives notification from FDA that Suitability Petition has been granted

NRx Pharmaceuticals (NRXP) announced that it was notified yesterday by the United States Food and Drug Administration that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product. Currently, ketamine is sold in multi-dose vials that contain Benzethonium Chloride, a toxic preservative. The Suitability Petition that has been granted enables immediate re-filing of the Company’s Abbreviated New Drug Application for KETAFREE. The Company believes that this proposed product addresses two critical policy objectives as articulated by the current administration: the re-shoring of strategically important drugs, particularly sterile products from foreign manufacturing sources, and the “Make America Healthy Again” objective of removing toxic preservatives and colorants from foods and drugs. These objectives have been articulated on numerous occasions by FDA and HHS leadership.