Posted by Michael Wonder on 31 Aug 2020
Mezzion shares tumble on FDA’s return of heart disease med NDA
31 August 2020 - Mezzion has announced it has received a complete response letter from the U.S. FDA over its submitted new drug application for udenafil, which is being developed to treat patients with single ventricle heart disease.
Mezzion submitted the new drug application to the FDA for review on June 30 based on Phase 3 clinical trial data.
The U.S. FDA requested the Korean drug company additional information and documentary correction, but no details were provided as to whether the request is related to the efficacy and safety profile of udenafil.
