Mezzion Announces Dr. Rahul Rathod of Boston Children's Hospital and Harvard
Mezzion Pharma Raises Nearly $40M to Advance a First-to-Market Treatment Option for Fontan Patients
SEOUL, South Korea, Feb. 21, 2023 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA).
SEOUL, South Korea and BETHESDA, Md. , May 31, 2022 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart disease (SVHD) in children with Fontan physiology. More specifically, Mezzion sought clarity on the critical elements of an additional clinical trial that may be needed to complete the NDA submission.
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 12 years of age and older with single ventricle heart disease (SVHD) who have undergone the Fontan operation. Udenafil is a long acting highly selective phosphodiesterase-5 inhibitor that is orally administered. The re-submitted NDA includes a request for Priority Review, which, if granted, may shorten the FDA's review of the re-submitted NDA to six months from the time of filing, versus a standard review timeline of 10 months from filing.
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 years of age and older with single ventricle heart disease (SVHD) who have undergone the Fontan operation. Udenafil is a long acting highly selective phosphodiesterase-5 inhibitor that is orally administered. The NDA includes a request for Priority Review, which, if granted, may shorten the FDA's review of the NDA to six months from the time of filing, versus a standard review timeline of 10 months from filing.
Mezzion Pharma announces that it has conducted a Type C Meeting with the FDA Regarding the TOP Line Data from the FUEL Phase 3 Clinical Trial