FDA flags packaging certification as sole major deficiency for NRx preservative-free ketamine ANDA approval
NRXP•Packaging certification remains the only major deficiency
FDA requested a manufacturer attestation on identical production lines and complaint-free history; the agency committed to the shortest possible review cycle.
The company said it has shipped 11.9 million units across three FDA-approved ANDA products using the same vial system in the past 12 months.
FDA first-cycle review found no major drug, labeling or CMC deficiencies
FDA completed first-cycle review of NRX Pharmaceuticals’ preservative-free ketamine ANDA with no major drug, labeling, or CMC deficiencies.
The outstanding item flagged as a Major Deficiency ties to container-closure performance evidence for a luer lock vial tip, not the ketamine formulation.
