Application Nr Approved Date Route Status External Links
NDA203496 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Orenitram Is A Prostacyclin Mimetic Indicated For The Treatment Of Pulmonary Arterial Hypertension (Pah) (Who Group 1): To Delay Disease Progression And To Improve Exercise Capacity. The Studies That Established Effectiveness Included Predominately Patients With Who Functional Class Ii-Iii Symptoms And Etiologies Of Idiopathic Or Heritable Pah (66%) Or Pah Associated With Connective Tissue Disease (26%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Orenitram Is Indicated For The Treatment Of Pulmonary Arterial Hypertension (Pah) (Who Group 1) To Delay Disease Progression And To Improve Exercise Capacity. The Studies That Established Effectiveness Included Predominately Patients With Who Functional Class Ii-Iii Symptoms And Etiologies Of Idiopathic Or Heritable Pah (66%) Or Pah Associated With Connective Tissue Disease (26%).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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