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NRx Pharmaceuticals has been granted FDA Fast Track designation for NRX-100 to treat suicidal ideation in patients with depression, including bipolar depression. This designation expands the addressable population to 13 million Americans, a 10x increase from the original designation in 2017. FDA has determined that NRX-100 has the potential to address an unmet need, aligning with the Commissioner's National Priority Voucher Program and the FDA's Accelerated Approval Program.
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