RegulatoryCompany release

FDA approves NRx's preservative-free ketamine generic ahead of GDUFA goal date

🇺🇸 NRX Pharmaceuticals, Inc. (NRXP) · Mon 02 Nov 2026

NRx says the agency cleared its ANDA for ketamine injection without benzethonium chloride, made by blow-fill-seal at Nephron, as a long-running shortage continues.

NRx Pharmaceuticals announced on 30 October 2026 that the US Food and Drug Administration has approved its abbreviated new drug application (ANDA) for Preservative-Free Ketamine injection. The decision came before the 10 November goal date set under the Generic Drug User Fee Amendments (GDUFA).

The product omits benzethonium chloride, an ingredient NRx has singled out in its regulatory activity. It is manufactured by blow-fill-seal technology at Nephron's site in South Carolina, according to the company.

NRx says the approval is intended to help ease a long-running shortage of ketamine. The company has not been quoted here on volumes or launch timing, and the summary available does not give details on either.

Separately, NRx has filed a Citizen Petition asking the FDA to remove benzethonium chloride from ketamine products. As general context, a Citizen Petition is a formal route for asking the agency to take or refrain from a regulatory action; the FDA is required to respond, but filing a petition does not in itself change any requirements.

What it means for your team

  • Supply-chain and market-access teams tracking ketamine should note a new ANDA-approved presentation without benzethonium chloride, though launch timing and capacity have not been stated.
  • Regulatory affairs teams should follow the FDA's response to the Citizen Petition, which could affect formulation expectations for ketamine products if the agency acts.
  • Quality teams may want to note the use of blow-fill-seal manufacturing at Nephron for this product.

Company's press release (SEC filing): NRX Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (NRX Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →