NRx Pharmaceuticals FDA ANDA review: no drug deficiencies; packaging issue to resolve

NRX Pharmaceuticals, Inc.

FDA first-round ANDA review for preservative-free ketamine found no major drug-component deficiencies (July 30, 2026).
One major deficiency: twist-off cap on luer lock vial; FDA wants confirmation no patient-safety risk from tip deformation.
Company cited 11.9M doses shipped across 3 approved ANDA products with same vial; 3,500 vials from 7 batches tested with no defects.
Aug 6 clarification meeting with FDA Office of Generic Drugs; FDA requested manufacturer certifications on same lines/machinery, committed to shortest review cycle.
FDA recognizes ketamine as strategic drug on shortage list; management optimistic for first commercial sales in 2026.

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