NRX Pharmaceuticals (NRXP) said Friday it plans to provide manufacturing attestation requested by the US Food and Drug Administration related to packaging for approval of its preservative-free ketamine's Abbreviated New Drug Application.
The agency has completed first-cycle review and found no major deficiencies related to the drug product, ingredients, proposed labeling, Chemistry, Manufacturing and Controls, or other drug-related review matters, NRX said.
Meanwhile, the agency found a major deficiency related to packaging in the first-cycle review of the drug, NRX said. The deficiency is related to evidence that the luer lock tip of the medication vial would perform properly when connected to a syringe by a licensed health professional, the company said.
NRX said it plans to provide manufacturing attestation requested by the agency that the product is manufactured on the same manufacturing lines with the same methods as three currently approved products.
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