NRx Pharmaceuticals Receives FDA Feedback on Preservative-Free Ketamine Label

Potential approval of ANDA expected in Summer 2026 as company aims to expand U.S. ketamine supply

Apr. 6, 2026 at 4:05pm

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An extreme macro, translucent X-ray photograph revealing the internal molecular structure of a glass vial of clear liquid medication as glowing, ghostly lines against a dark background, conceptually representing the company's new preservative-free ketamine product.NRx's preservative-free ketamine formulation could help address supply shortages and align with government initiatives to boost domestic production of critical medications.Austin Today

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has received a letter from the FDA Office of Generic Drugs with only minor formatting comments on the proposed label for its preservative-free ketamine product. The company expects to submit a final label this month and anticipates potential approval of its Abbreviated New Drug Application (ANDA) in Summer 2026 pending final review. NRx noted the product could help expand the U.S. ketamine supply amid reported shortages and aligns with federal efforts to re-shore critical drug manufacturing.

Why it matters

Ketamine has shown promise in treating severe depression and suicidal ideation, but supply shortages have limited access. NRx's preservative-free formulation could help address this issue and align with government initiatives to boost domestic production of critical medications. Approval of this ANDA would mark an important milestone for the company's pipeline of NMDA-based therapies for central nervous system disorders.

The details

NRx Pharmaceuticals received feedback from the FDA's Office of Generic Drugs on the proposed label for its preservative-free ketamine product. The agency indicated only minor formatting comments, allowing NRx to submit a final label this month. The company anticipates potential approval of its ANDA in Summer 2026 pending final FDA review. NRx noted the product could help expand the U.S. ketamine supply, which has faced reported shortages, while also aligning with federal efforts to re-shore critical drug manufacturing. In addition to the ANDA, NRx continues advancing a Fast Track-designated New Drug Application (NDA) to evaluate intravenous ketamine for severe depression with suicidal ideation.

  • NRx expects to submit a final label for its preservative-free ketamine product this month.
  • Potential approval of the company's ANDA is anticipated in Summer 2026 pending final FDA review.

The players

NRx Pharmaceuticals, Inc.

A clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD.

FDA Office of Generic Drugs

The division of the U.S. Food and Drug Administration responsible for reviewing and approving generic drug applications.

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What’s next

NRx expects to submit a final label for its preservative-free ketamine product this month, with potential approval of its ANDA anticipated in Summer 2026 pending final FDA review.

The takeaway

NRx's preservative-free ketamine formulation could help address supply shortages and align with government initiatives to boost domestic production of critical medications, marking an important milestone for the company's pipeline of NMDA-based therapies for central nervous system disorders.