Posted by Michael Wonder on 15 Nov 2016
Eagle Pharmaceuticals initiates rolling submission of NDA for Ryanodex in exertional heat stroke
11 November 2016 - Eagle Pharmaceuticals today announced that the Company has initiated the rolling submission of its new drug application and filed the first part of the application to the U.S. FDA for Ryanodex (dantrolene sodium) for injectable suspension for the treatment of exertional heat stroke, an investigational new indication for the product.
The rolling submission allows completed portions of an NDA to be submitted, which may then be reviewed by the FDA on an ongoing basis. The FDA had previously granted Fast Track Designation for the development of Ryanodex for the treatment of exertional heat stroke, which allows for submission of parts of an NDA application (rolling review).
