NRx Pharmaceuticals receives FDA feedback on ketamine drug application
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NRx Pharmaceuticals Reports Positive FDA Office of Generic Drugs Feedback on Preservative-Free Ketamine Program
April 22, 2026 7:00 AM EDTNRx has received a positive review letter (Discipline Review Letter) addressing Drug Quality requesting only Minor administrative changesNRx conducted a meeting with leadership of the FDA Office of Generic Drugs in which support was voiced for the potential approval of the Abbreviated New Drug Application within the current review cycle.Ketamine is identified as medically necessary by the US Department of Veterans Affairs for the treatment of suicidality and treatment-resistant depression.In addition to the... More
