Posted by Michael Wonder on 27 May 2021
Mezzion's new drug application for its orphan drug udenafil for the treatment of single ventricle heart disease has been accepted for filing by the FDA
25 May 2021 - Mezzion Pharma is pleased to announce today that it has received notice from the FDA that its new drug application submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review.
In the FDA notice, the FDA advised that there were no filing review issues identified. Thus, the FDA review cycle has started with an expected approval date of 26 March 2022.
The FDA also advised in the FDA notice that the FDA is not currently planning to hold an advisory committee meeting to discuss Mezzion's new drug application.
