NRx says FDA restarts review of preservative-free ketamine ANDA after vial-cap concern flagged
NRXP•Manufacturer certifications requested
The FDA also requested signed manufacturer certifications that the product uses the same lines, machinery, and materials as three marketed ANDA products.
NRx said the FDA committed to restart the review immediately, with the goal of resolving the packaging issue in the shortest possible cycle.
Company expects 2026 commercial launch
NRx Pharmaceuticals said it expects the issue can be cleared in time to support first commercial sales in 2026.
FDA review restarts after packaging concern
NRx Pharmaceuticals said the FDA has restarted its review of the company's preservative-free ketamine ANDA after the agency flagged a concern tied to the luer lock vial twist-off cap. The FDA said the tip could deform in clinical use.
NRx said the FDA first-round ANDA review found no major drug-component deficiencies.
