Also known as: suicidal ideation in depression, Suicidal ideation in Depression, Suicidal Ideation in Depression
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
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 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 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.
