NRx Pharmaceuticals (Nasdaq:NRXP) Receives FDA Approval of Preservative-Free Ketamine Ahead of November 10 FDA Goal Date
NRx Pharmaceuticals received FDA approval of its ANDA for Preservative-Free Ketamine, ahead of the November 10 GDUFA goal date. The approval covers the only ketamine injection formulation free of benzethonium chloride, a preservative the FDA has declined to designate as GRAS, and the drug remains on the FDA shortage list since 2018. The company has commercial supply on hand manufactured with Nephron Pharmaceuticals in South Carolina and will now label and distribute to U.S. hospitals and clinics for anesthesia and pain control.
Key figures
- Drug Name
- Preservative-Free Ketamine
- Phase Of Trial
- N/A (ANDA generic approval)
- Approval type
- ANDA
- Gdufa goal date
- November 10, 2026
- Darpa contract usd
- 11250000
- Benzethonium chloride exposure limit
- 1 milligram FDA maximum daily exposure
AI analysis
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