NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure.
On September 3, 2021, NRx received a request for additional clinical information from the FDA and plans to respond to this information request within a week. Ongoing conversations between the FDA and sponsor of any application to the FDA are normal, expected, and important to the FDA’s review process.
NRx has responded to three prior information requests since filing the EUA application on May 31, 2021. FDA’s review of NRx’s EUA application remains ongoing.
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