Submitted for FDA Priority Review as a Rare Pediatric Disease Product Application SEOUL, South Korea, March 28, 2021 /PRNewswire/ — Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has re-submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of udenafil to improve the exercise capacity of patients […]
Tag: SVHD
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
Submitted for FDA Priority Review as a Rare Pediatric Disease Product Application SEOUL, South Korea, June 30, 2020 /PRNewswire/ — Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of udenafil to improve the physiology of patients 12 […]



