FDA completes first-cycle review of NRx ketamine ANDA with packaging query
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FDA Completes First-Cycle Review of Preservative-Free Ketamine ANDA with No Drug Related Major Deficiencies; Final Packaging Certification Requested for Approval
August 7, 2026 7:00 AM EDTFDA identified no major deficiencies related to the ketamine drug product, ingredients, proposed labeling, CMC, or other drug-related review matters.Remaining item relates to manufacturer certification for a luer lock vial already used in three FDA-approved ANDA products with 11.9 million units shipped over the past 12 months without complaints, returns, adverse events, or recalls.No new clinical, safety, efficacy, or drug-related data are required for ANDA approval.Following an August 6, 2026 clarification meeting attended by senior FDA leadership, FDA committed... More
