Posted by Michael Wonder on 01 Jul 2020
Mezzion announces submission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
30 June 2020 - Mezzion Pharma announced today that it has submitted a new drug application to the U.S. FDA for the approval of udenafil to improve the physiology of patients 12 years of age and older with single ventricle heart disease who have undergone the Fontan operation.
Udenafil is a long acting highly selective phosphodiesterase 5 inhibitor that is orally administered.
The application includes a request for priority review, which, if granted, may shorten the FDA's review of the application to six months from the time of filing, versus a standard review timeline of 10 months from filing.
