NRx Pharmaceuticals (NASDAQ: NRXP) announced that the FDA has completed its first-cycle review of the company's Abbreviated New Drug Application (ANDA) for preservative-free ketamine, finding no major deficiencies related to the drug product, its ingredients, proposed labeling, or Chemistry, Manufacturing and Controls matters.

The FDA identified one remaining item classified as a major deficiency due to its relation to the product's container closure system — specifically, a question about whether the luer lock tip of the medication vial would perform properly when connected to a syringe. The company says the same luer lock vial is already used in three currently FDA-approved ANDA products, with 11.9 million doses shipped in the U.S. over the past 12 months without complaints, returns, recalls, or adverse events.

NRx held a clarification meeting with FDA on August 6, 2026, attended by leadership from the FDA Center for Drug Evaluation and Research and the Office of Generic Drugs. At that meeting, FDA requested a manufacturer attestation confirming the product is made on the same lines and with the same methods as currently approved products, along with an attestation of the complaint-free history. The company said it has submitted the attestation, and FDA committed to reviewing it in the shortest possible review cycle.

No new clinical, safety, or efficacy data are required for ANDA approval, according to the company's statement.

NRx noted that industry data indicate only 14% to 18% of ANDA products receive approval during first-cycle review.

"FDA identified no major deficiencies related to the drug product, ingredients, proposed labeling, CMC, or other drug-related review matters," said Jonathan Javitt, MD, MPH, founder and chief executive officer of NRx Pharmaceuticals.

NRx management is scheduled to host a conference call on August 10, 2026, at 8:30 a.m. ET to discuss the regulatory update and commercialization plans.