Application Nr Approved Date Route Status External Links
NDA022387 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tyvaso Is Indicated For The Treatment Of Pulmonary Arterial Hypertension (Pah) (Who Group 1) To Improve Exercise Ability. Studies Establishing Effectiveness Included Predominately Patients With Nyha Functional Class Iii Symptoms And Etiologies Of Idiopathic Or Heritable Pah (56%) Or Pah Associated With Connective Tissue Diseases (33%). The Effects Diminish Over The Minimum Recommended Dosing Interval Of 4 Hours; Treatment Timing Can Be Adjusted For Planned Activities. While There Are Long-Term Data On Use Of Treprostinil By Other Routes Of Administration, Nearly All Controlled Clinical Experience With Inhaled Treprostinil Has Been On A Background Of Bosentan (An Endothelin Receptor Antagonist) Or Sildenafil (A Phosphodiesterase Type 5 Inhibitor). The Controlled Clinical Experience Was Limited To 12 Weeks In Duration [See Clinical Studies (14) ] . Tyvaso Is A Prostacyclin Vasodilator Indicated For The Treatment Of Pulmonary Arterial Hypertension (Pah; Who Group 1) To Improve Exercise Ability. Studies Establishing Effectiveness Included Predominately Patients With Nyha Functional Class Iii Symptoms And Etiologies Of Idiopathic Or Heritable Pah (56%) Or Pah Associated With Connective Tissue Diseases (33%). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Treprostinil TREPROSTINIL ZINC3800475

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