Posted by Michael Wonder on 29 Mar 2021
Mezzion announces resubmission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
28 March 2021 - Submitted for FDA priority review as a rare paediatric disease product application.
Mezzion Pharma announced today that it has resubmitted a new drug application to the U.S. FDA for the approval of udenafil to improve the exercise capacity of patients 12 years of age and older with single ventricle heart disease (SVHD) who have undergone the Fontan operation.
The resubmitted new drug application includes a request for priority review, which, if granted, may shorten the FDA's review of the resubmitted application to six months from the time of filing, versus a standard review timeline of 10 months from filing.
