Application Nr Approved Date Route Status External Links
NDA021272 2002-05-21 Intravenous RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Remodulin Is A Prostacyclin Vasodilator Indicated For: Treatment Of Pulmonary Arterial Hypertension (pah) (who Group 1) To Diminish Symptoms Associated With Exercise. Studies Establishing Effectiveness Included Patients With Nyha Functional Class Ii-Iv Symptoms And Etiologies Of Idiopathic Or Heritable Pah (58%), Pah Associated With Congenital Systemic-To-Pulmonary Shunts (23%), Or Pah Associated With Connective Tissue Diseases (19%) (1.1) Patients Who Require Transition From FlolanĀ®, To Reduce The Rate Of Clinical Deterioration. The Risks And Benefits Of Each Drug Should Be Carefully Considered Prior To Transition. (1.2) 1.1 Pulmonary Arterial Hypertension Remodulin Is Indicated For The Treatment Of Pulmonary Arterial Hypertension (pah) (who Group 1) To Diminish Symptoms Associated With Exercise. Studies Establishing Effectiveness Included Patients With Nyha Functional Class Ii-Iv Symptoms And Etiologies Of Idiopathic Or Heritable Pah (58%), Pah Associated With Congenital Systemic-To-Pulmonary Shunts (23%), Or Pah Associated With Connective Tissue Diseases (19%) [see Clinical Studies (14.1)]. It May Be Administered As A Continuous Subcutaneous Infusion Or Continuous Intravenous (iv) Infusion; However, Because Of The Risks Associated With Chronic Indwelling Central Venous Catheters, Including Serious Blood Stream Infections (bsis), Reserve Continuous Intravenous Infusion For Patients Who Are Intolerant Of The Subcutaneous Route, Or In Whom These Risks Are Considered Warranted [see Warnings And Precautions 5.1]. 1.2 Pulmonary Arterial Hypertension In Patients Requiring Transition From FlolanĀ® In Patients With Pulmonary Arterial Hypertension Requiring Transition From Flolan (epoprostenol Sodium), Remodulin Is Indicated To Diminish The Rate Of Clinical Deterioration. Consider The Risks And Benefits Of Each Drug Prior To Transition.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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