The FDA’s decision is based on GMP (Good Manufacturing Practice) observations at the company’s contract manufacturer. No observations were directed at the production line used for Dasynoc, but the FDA is pausing approvals of new products at the facility while corrective actions are being implemented, states the company.

“It is unfortunate that manufacturing-related issues beyond our control are delaying our launch. We have made significant progress in the regulatory review and maintained discussions with the FDA regarding the product information for Dasynoc up to the PDUFA date,” says Per Andersson, CEO of Xspray Pharma. “We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed.” 

The manufacturer has confirmed that a remediation plan is already in place and that a meeting with the FDA is scheduled for December. 

The FDA has also requested information demonstrating that the discussed product information is appropriate and data confirming the outcome of previously implemented corrective actions at the production line, describes the company.