Application Nr Approved Date Route Status External Links
NDA021845 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sildenafil Is Indicated For The Treatment Of Pulmonary Arterial Hypertension (who Group I) In Adults To Improve Exercise Ability And Delay Clinical Worsening. The Delay In Clinical Worsening Was Demonstrated When Sildenafil Was Added To Background Epoprostenol Therapy [see Clinical Studies (14) ] . Studies Establishing Effectiveness Were Short-Term (12 To 16 Weeks), And Included Predominately Patients With New York Heart Association (nyha) Functional Class Ii–iii Symptoms And Idiopathic Etiology (71%) Or Associated With Connective Tissue Disease (ctd) (25%). Sildenafil Is A Phosphodiesterase-5 (pde-5) Inhibitor Indicated For The Treatment Of Pulmonary Arterial Hypertension (pah) (who Group I) In Adults To Improve Exercise Ability And Delay Clinical Worsening. Studies Establishing Effectiveness Were Short-Term (12 To 16 Weeks), And Included Predominately Patients With Nyha Functional Class Ii–iii Symptoms. Etiologies Were Idiopathic (71%) Or Associated With Connective Tissue Disease (25%). ( 1 ) Limitation Of Use : Adding Sildenafil To Bosentan Therapy Does Not Result In Any Beneficial Effect On Exercise Capacity. ( 1 , 14 ) Limitation Of Use: Adding Sildenafil To Bosentan Therapy Does Not Result In Any Beneficial Effect On Exercise Capacity [see Clinical Studies (14) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sildenafil Citrate SILDENAFIL CITRATE ZINC895081

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