Published in Health Insurance Week, July 23rd, 2006
The new PDUFA date will be October 30, 2006. The additional time is needed to allow the FDA sufficient time to review the final study report of the recently completed thorough QT study.
"While we are disappointed that there will be a delay in hearing about the status of the Neurodex NDA, we believe the QT data provides added support to the safety profile of the drug,"...
Want to see the full article?
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Health Insurance Week