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NRx Pharmaceuticals Wins FDA Approval for Generic Preservative-Free Ketamine KETAFREE Ahead of Deadline

By Market Flux··1 min read
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NRx Pharmaceuticals, Inc. $NRXP

$2.29-13.26%as of publication

5D Change
-7.66%
Notional
$35M

NRx Pharmaceuticals received FDA approval on October 30 for its generic preservative-free ketamine injection, branded as KETAFREE, beating the agency's November 10 GDUFA goal date. The company had filed an Abbreviated New Drug Application in September 2025, and the FDA completed its first-cycle review with no drug-related major deficiencies before issuing final approval. The product is a preservative-free formulation of ketamine for intravenous infusion, positioned as a generic alternative in the existing ketamine market.

NRx said commercial supply is already ready for hospitals and clinics, allowing the company to begin selling immediately without waiting to build post-approval inventory. Shares of NRXP surged more than 26% in after-hours trading ahead of the announcement and were trading roughly 12-14% higher in the premarket session on the day of approval, with the stock gapping up alongside a broader set of movers at the open.

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  1. InvestingNRx Pharmaceuticals receives FDA approval for ketamine drug
  2. Seeking AlphaNRx Pharma rises on FDA nod for generic ketamine injection
  3. BriefingcomGapping up: $NRXP +12.4% $CPRI +9.1% $CDNA +7.2% $MDLZ +6.5% $RIVN +6.1% Gapping down: $ABOS -78.9% $ATEC -32% $INTC -24.7% $RDDT -20.9% $TWLO -19.2% $RBLX -16.1%
  4. OpenOutcrier$NRXP (+13.9% pre) FDA approves NRx preservative-free ketamine ahead of deadline
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