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.
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
Mezzion has hired Pol Pharma and Halo Pharma and accused former CMO Dr Reddy’s of hiding manufacturing problems that cost its erectile dysfunction candidate, udenafil, US approval.
Mezzion said Tuesday that it had filed the case in New Jersey state court alleging that Dr. Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations, while it was not, and that Dr. Reddy's misconduct “was the sole reason given by the FDA” to deny approval of Mezzion's NDA for udenafil for the treatment of erectile dysfunction. It cites a warning letter that Dr. Reddy’s received in 2015 for three plants in India.
Mezzion Pharma Co. Ltd., announced that the Food and Drug Administration (FDA) recently completed a special protocol assessment (SPA) review of two Phase 3 clinical protocols directed to the use of Mezzion Pharma's extended half-life phosphodiesterase type 5 inhibitor (PDE5i) udenafil in adolescents with single ventricle congenital heart disease with Fontan physiology. As this disease affects fewer than 200,000 people in the USA, udenafil was designated as an orphan drug by FDA in 2015.