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Company awaits final packaging certification for approval.
NRx Pharmaceuticals, Inc. (NRXP) announced on August 7, 2026, that the U.S. Food and Drug Administration (FDA) has completed its first-cycle review of the company's Abbreviated New Drug Application (ANDA) for preservative-free ketamine. The review identified no drug-related major deficiencies.
The FDA has requested final packaging certification to proceed with approval. This step is necessary to ensure the product meets all regulatory standards before it can be marketed.
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