NRXP: FDA Clears First-Cycle Review Of Preservation-Free Ketamine ANDA; Approval Awaits Vial Cert

NRx Pharmaceuticals said the FDA completed its first-cycle review of its preservative-free ketamine ANDA, finding no major deficiencies in the drug product, labeling, or manufacturing. This regulatory clearance milestone reduces near-term approval risk for the ANDA, though the article does not indicate final approval timing.

Analysis

NRx Pharmaceuticals said the FDA completed its first-cycle review of its preservative-free ketamine ANDA, finding no major deficiencies in the drug product, labeling, or manufacturing. This regulatory clearance milestone reduces near-term approval risk for the ANDA, though the article does not indicate final approval timing.