Application Nr Approved Date Route Status External Links
NDA203496 2016-10-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Orenitram Is A Prostacyclin Vasodilator Indicated For: Treatment Of Pulmonary Arterial Hypertension (pah) (who Group 1) To Improve Exercise Capacity. The Study That Established Effectiveness Included Predominately Patients With Who Functional Class Ii-Iii Symptoms And Etiologies Of Idiopathic Or Heritable Pah (75%) Or Pah Associated With Connective Tissue Disease (19%). (1.1) As The Sole Vasodilator, The Effect On Exercise Is Small. Orenitram Has Not Been Shown To Add To Other Vasodilator Therapy. (1.1) 1.1 Pulmonary Arterial Hypertension Orenitram Is Indicated For The Treatment Of Pulmonary Arterial Hypertension (pah) (who Group 1) To Improve Exercise Capacity. The Study That Established Effectiveness Included Predominately Patients With Who Functional Class Ii-Iii Symptoms And Etiologies Of Idiopathic Or Heritable Pah (75%) Or Pah Associated With Connective Tissue Disease (19%). When Used As The Sole Vasodilator, The Effect Of Orenitram On Exercise Is About 10% Of The Deficit, And The Effect, If Any, On A Background Of Another Vasodilator Is Probably Less Than This.

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
2. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose Acetate CELLULOSE ACETATE Unresolved
5. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
6. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
10. Alcohol ALCOHOL Molecular
11. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
12. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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