KETAFREE

August 7, 2026: NRx Pharmaceuticals (NASDAQ: NRXP) said FDA completed first-cycle review of its ANDA for preservative-free ketamine with no major deficiencies related to the drug product, ingredients, proposed labeling, CMC, or other drug-related matters, and no new clinical, safety, efficacy, or drug-related data are required for approval. The only remaining issue is a packaging/container-closure question classified as a major deficiency: certification that the luer lock vial tip performs properly and is manufactured on the same lines and by the same methods as approved products.

At an August 6, 2026 clarification meeting with FDA/CDER and the Office of Generic Drugs, FDA requested a manufacturer attestation and complaint-history certification. NRx said the same luer lock vial is used in three approved ANDA products that shipped 11.9 million units in the last 12 months without complaints, returns, recalls, or adverse events; NRx also submitted testing on more than 3,500 vials from seven lots with no failures. FDA committed to review the certification in the shortest possible review cycle.

Upcoming catalyst: NRx will host a regulatory update conference call on August 10, 2026, at 8:30 a.m. ET.