FDA sets PDUFA-date for Xspray Pharma's re-submitted application for Dasynoc®

MAR

The U.S. Food and Drug Administration (FDA) has acknowledged receipt of Xspray Pharma's re-submitted NDA (New Drug Application) for Dasynoc®. 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.

“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.

Datum 2025-05-14, kl 21:10
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