KETAFREE

September 15, 2026: NRx Pharmaceuticals (NASDAQ: NRXP) said the FDA Office of Generic Drugs reclassified an amendment to its ANDA for the drug vial for preservative-free ketamine from a Major Amendment to a Minor Amendment. As a result, the FDA revised the Generic Drugs User Fee Act (GDUFA) goal date to November 10, 2026, stating the reclassified amendment will not require a substantial expenditure of FDA resources.

The filing relates to NRX-100, described by the company as preservative-free intravenous ketamine. The release frames the product as addressing a drug shortage. The company also said it has filed an ANDA and initiated an NDA filing for NRX-100 for suicidal ideation in patients with depression, including bipolar depression, with an application to the Commissioner’s National Priority Voucher Program.

Other program status mentioned: NRX-100 has Fast Track designation for suicidal ideation in depression, including bipolar depression; NRX-101 (oral D-cycloserine/lurasidone) has Breakthrough Therapy designation for suicidal bipolar depression.