News Related to FDA Division of Psychiatry Products

FDA meeting points to NRX-100 NDA supported by clinical and real-world ketamine data

Apr 06, 2026

NRx Pharmaceuticals said an FDA Type C meeting indicated a path to an NDA for NRX-100, using clinical trial results and real-world ketamine data from more than 65,000 patients.

NRx Pharmaceuticals Completes FDA Meeting on NRX-100 for Suicidal Depression

Feb 28, 2026

NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.

NRx Pharmaceuticals Charts Path to NDA for NRX-100 Following FDA Guidance

Feb 17, 2026

NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.

NRx Pharmaceuticals Receives FDA Guidance on New Drug Application Path for NRX-100

Feb 17, 2026

NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.