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Udenafil FDA Approval Status

FDA Approved: No
Generic name: udenafil
Company: Mezzion Pharma Co. Ltd.
Treatment for: Single Ventricle Heart Disease

Udenafil is a long acting, highly selective phosphodiesterase-5 inhibitor in development for the treatment of patients who have undergone the Fontan operation for single ventricle heart disease.

Development Timeline for udenafil

DateArticle
Mar 28, 2021Mezzion Announces Re-Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
Jun 30, 2020Mezzion 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

Further information

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