FDA grants Suitability Petition for NRx's preservative-free ketamine, enabling ANDA re-filing

NRX Pharmaceuticals, Inc.

FDA approved Suitability Petition for proposed strength of NRx's single-patient, preservative-free ketamine (KETAFREE™).
Currently marketed ketamine uses multi-dose vials with toxic preservative Benzethonium Chloride; KETAFREE™ is preservative-free.
Suitability Petition grant enables immediate re-filing of Abbreviated New Drug Application (ANDA) for KETAFREE™.
NRx estimates total ketamine market at $750M; product aligns with FDA/HHS policy on removing toxic preservatives.
NRx CEO noted rapid FDA response after company attended listening session with FDA Commissioner.

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