FDA flags packaging certification as sole major deficiency for NRx preservative-free ketamine ANDA approval

Reuters2026/08/07 11:01

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FDA completed first-cycle review of NRX Pharmaceuticals’ preservative-free ketamine ANDA with no major drug, labeling, or CMC deficiencies.
Outstanding item flagged as a Major Deficiency ties to container-closure performance evidence for a luer lock vial tip, not the ketamine formulation.
FDA requested a manufacturer attestation on identical production lines and complaint-free history; agency committed to the shortest possible review cycle.
Company cited 11.9 million units shipped across three FDA-approved ANDA products using the same vial system in the past 12 months.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608070700PRIMZONEFULLFEED9805852) on August 07, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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FDA flags packaging certification as sole major deficiency for NRx preservative-free ketamine ANDA approval

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