FDA Reclassifies NRX PHARMACEUTICALS (NRXP) Ketamine Filing to Minor Amendment
NRx says the FDA downgraded an ANDA amendment for preservative-free ketamine from major to minor and set a new GDUFA goal date of November 10, 2026.
NRx Pharmaceuticals (NRXP) said it has received written notice from the Director of Regulatory Operations at the FDA Office of Generic Drugs that an amendment to its Abbreviated New Drug Application for preservative-free ketamine, previously classified as a Major Amendment, has been reclassified as a Minor Amendment. The agency also revised the review goal date under the Generic Drugs User Fee Act to November 10, 2026.
