Application Nr Approved Date Route Status External Links
ANDA208800 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Deferiprone Tablets Are 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) ]. Limitation Of Use: Safety And Effectiveness Have Not Been Established For The Treatment Of Transfusional Iron Overload In Patients With Other Chronic Anemias. Deferiprone 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 ). Limitation 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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