Ferriprox

Product manufactured by Apopharma Usa, Inc.

Application Nr Approved Date Route Status External Links
NDA021825 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ferriprox ® Is Indicated For The Treatment Of Patients With Transfusional Iron Overload Due To Thalassemia Syndromes When Current Chelation Therapy Is Inadequate. Approval Is Based On A Reduction In Serum Ferritin Levels. There Are No Controlled Trials Demonstrating A Direct Treatment Benefit, Such As Improvement In Disease-Related Symptoms, Functioning, Or Increased Survival [See Clinical Studies (14) ] . Limitations Of Use Safety And Effectiveness Have Not Been Established For The Treatment Of Transfusional Iron Overload In Patients With Other Chronic Anemias. Ferriprox ® Is An Iron Chelator Indicated For The Treatment Of Patients With Transfusional Iron Overload Due To Thalassemia Syndromes When Current Chelation Therapy Is Inadequate. (1) Approval Is Based On A Reduction In Serum Ferritin Levels. There Are No Controlled Trials Demonstrating A Direct Treatment Benefit, Such As Improvement In Disease-Related Symptoms, Functioning, Or Increased Survival. (1) Limitations Of Use Safety And Effectiveness Have Not Been Established For The Treatment Of Transfusional Iron Overload In Patients With Other Chronic Anemias. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Deferiprone DEFERIPRONE ZINC6226

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