NRx Pharmaceuticals, Inc. filed an 8-K on November 2, 2026, reporting that the U.S. Food and Drug Administration approved the company's Abbreviated New Drug Application for Preservative-Free Ketamine on October 30, 2026.

Key Highlights

  • FDA Approval Received: The FDA approved NRx Pharmaceuticals' ANDA for Preservative-Free Ketamine, according to the filing.
  • Ahead of Goal Date: The approval came before the November 10, 2026 GDUFA goal date established under the Generic Drug User Fee Amendments.
  • Event Date: The earliest event reported is October 30, 2026.
  • Conference Call Held: The company hosted a conference call and live webcast at 8:30 a.m. Eastern Time on October 30, 2026 to discuss the approval.
  • Signed by CFO: The filing was signed by Michael Abrams, Chief Financial Officer, on November 2, 2026.

FDA Clears NRx Pharmaceuticals' Generic Ketamine Application Before GDUFA Deadline

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) disclosed in a Form 8-K filed November 2, 2026, that it received FDA approval for its Abbreviated New Drug Application for Preservative-Free Ketamine. According to the filing, the approval was granted on October 30, 2026, ahead of the November 10, 2026 goal date set under the Generic Drug User Fee Amendments (GDUFA).

The disclosure was made under Item 7.01 (Regulation FD Disclosure). The company also reported that it held a conference call and live webcast at 8:30 a.m. Eastern Time on October 30, 2026 to discuss the approval with interested parties. The press release announcing the approval was filed as Exhibit 99.1 to the Current Report.

The filing contains forward-looking statements, which the company states "are subject to significant risks and uncertainties, many of which are beyond the Company's control, that could cause actual results to differ materially from those expressed or implied by such statements." The company notes it undertakes no obligation to publicly update or revise any forward-looking statement except as required by applicable law.

What Was Disclosed

NRx Pharmaceuticals filed an 8-K disclosing FDA approval of its ANDA for Preservative-Free Ketamine, received October 30, 2026, before the GDUFA goal date of November 10, 2026. A related press release was attached as Exhibit 99.1.