On May 14, 2025 Xspray Pharma reported that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Xspray Pharma’s re-submitted NDA (New Drug Application) for Dasynoc (Press release, Xspray, MAY 14, 2025, View Source [SID1234653475]). The re-submission is based on a CRL (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. Xspray Pharma is now continuing to prepare for the US launch of Dasynoc with the aim that it can begin as soon as possible if market approval is received in October.

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"I am pleased that we now have a PDUFA date, and with that date now set we continue to prepare for a successful launch of Dasynoc as soon as we receive market approval. At such point we will be ready to offer ALL and CML patients in the US Dasynoc, a dasatinib drug with important advantages compared to today’s treatment options," says Per Andersson, CEO of Xspray Pharma.

The acknowledgement from the FDA was received a week after the FDA was expected to communicate a PDUFA date, but the Authority did not specify a reason for the delay.