NRx says FDA restarts review of preservative-free ketamine ANDA after vial-cap concern flagged

• NRx Pharmaceuticals received an FDA first-round ANDA review for preservative-free ketamine with no major drug-component deficiencies.
• FDA flagged one major deficiency tied to the luer lock vial twist-off cap, citing concern the tip could deform in clinical use.
• FDA requested signed manufacturer certifications that the product uses the same lines, machinery, and materials as three marketed ANDA products.
• FDA committed to restart review immediately, targeting the shortest possible cycle to resolve the packaging issue.
• NRx Pharmaceuticals expects the issue can be cleared in time to support first commercial sales in 2026.

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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001437749-26-026428), on August 07, 2026, and is solely responsible for the information contained therein.