NRx Pharmaceuticals Announces Progress on Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)
Retrieved on:
Tuesday, October 12, 2021
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This module will now be used as part of the FDA's rolling review process supporting the New Drug Application for ZYESAMI.
Key Points:
- This module will now be used as part of the FDA's rolling review process supporting the New Drug Application for ZYESAMI.
- NRx awaits a QP Declaration that is required by the EU regulatory authorities for the release of ZYESAMI.
- The audit was completed in preparation for submission of European Union (EU)-standard ZYESAMI to EU and United Kingdom health regulatory authorities.
- NRx Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific, and drug-development experience to bring improved health to patients.