NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Applies for FDA Commissioner’s National Priority Voucher for IV Ketamine NRX-100
The new FDA voucher program aims to speed approval of drugs aligned with national health priorities. NRX-100, a preservative-free ketamine, is also under an Abbreviated New Drug Application (“ANDA”) with a priority review request. NRx has submitted full CMC data and draft labeling for NRX-100, meeting key Commissioner’s National Priority Voucher pre-qualification criteria. The company’s U.S.-based manufacturing aims to reduce foreign supply chain dependence and address diversion concerns. A patent on the preservative-free process and a citizen petition to withdraw preserved ketamine could bolster NRx’s market position. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and…
