NRx Pharmaceuticals, Inc. (NRXP) — NRx Pharmaceuticals said the FDA granted its suitability petition for the proposed strength of its single-patient, preservative-free ketamine product (marketed as KETAFREE).

The approval clears a procedural step supporting NRx's planned NDA for NRX-100 (IV ketamine) in suicidal depression, a program that holds Fast Track designation. It advances the company's path toward a potential 2026 regulatory decision.

Source: globenewswire.com

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