Posted by Michael Wonder on 15 May 2025
FDA sets PDUFA date for Xspray Pharma’s re-submitted application for Dasynoc
14 May 2025 - The US FDA has acknowledged receipt of Xspray Pharma's re-submitted new drug application) for Dasynoc.
The re-submission is based on a complete response letter received from the FDA in July 2024 where additional information was requested.
The FDA has now set the PDUFA date to 7 October 2025, which is the FDA's deadline for communicating its decision on the company's application.
