NRx Pharmaceuticals (Nasdaq: NRXP) Reports Update from the FDA Revising Previous Major Amendment to a Minor Amendment for Preservative-free Ketamine
NRx Pharmaceuticals said the FDA reclassified the amendment to its Abbreviated New Drug Application for preservative-free ketamine (NRX-100) from a Major Amendment to a Minor Amendment. The agency reset the GDUFA review goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources. Chairman and CEO Dr. Jonathan Javitt praised the pace of the review, describing preservative-free ketamine as a strategic drug-shortage product.
Key figures
- Drug Name
- preservative-free ketamine (NRX-100)
- Gdufa goal date
- November 10, 2026
- Application type
- Abbreviated New Drug Application (ANDA)
- Amendment classification
- Minor Amendment
- Prior amendment classification
- Major Amendment
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