WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) moved closer to a potential 2026 launch of preservative-free ketamine after the Food and Drug Administration found no major deficiencies involving the drug or its manufacture during an initial application review, leaving a packaging-related matter as the remaining issue.
The FDA requested an attestation that the vial’s syringe-connection component is manufactured in the same manner as those used for three approved drugs, according to NRx. The company has submitted the document, but the application remains under review.
NRx has begun producing 5 million doses as potential launch inventory and plans to manufacture 1 million doses a month after commercialization. It also appointed Glenn Tyson as its first chief commercial officer and retained a launch team…