Application Nr Approved Date Route Status External Links
NDA022291 2012-11-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Promacta Is A Thrombopoietin Receptor Agonist Indicated For The Treatment Of: Thrombocytopenia In Adult And Pediatric Patients 1 Year And Older With Chronic Immune (idiopathic) Thrombocytopenia (itp) Who Have Had An Insufficient Response To Corticosteroids, Immunoglobulins, Or Splenectomy. Promacta Should Be Used Only In Patients With Itp Whose Degree Of Thrombocytopenia And Clinical Condition Increase The Risk For Bleeding. (1.1) Thrombocytopenia In Patients With Chronic Hepatitis C To Allow The Initiation And Maintenance Of Interferon-Based Therapy. Promacta Should Be Used Only In Patients With Chronic Hepatitis C Whose Degree Of Thrombocytopenia Prevents The Initiation Of Interferon-Based Therapy Or Limits The Ability To Maintain Interferon-Based Therapy. (1.2) Patients With Severe Aplastic Anemia Who Have Had An Insufficient Response To Immunosuppressive Therapy. (1.3) Limitations Of Use: Promacta Is Not Indicated For The Treatment Of Patients With Myelodysplastic Syndrome (mds). (1.4) Safety And Efficacy Have Not Been Established In Combination With Direct-Acting Antiviral Agents Used Without Interferon For Treatment Of Chronic Hepatitis C Infection. (1.4) 1.1 Treatment Of Thrombocytopenia In Patients With Chronic Itp Promacta Is Indicated For The Treatment Of Thrombocytopenia In Adult And Pediatric Patients 1 Year And Older With Chronic Immune (idiopathic) Thrombocytopenia (itp) Who Have Had An Insufficient Response To Corticosteroids, Immunoglobulins, Or Splenectomy. Promacta Should Be Used Only In Patients With Itp Whose Degree Of Thrombocytopenia And Clinical Condition Increase The Risk For Bleeding. 1.2 Treatment Of Thrombocytopenia In Patients With Hepatitis C Infection Promacta Is Indicated For The Treatment Of Thrombocytopenia In Patients With Chronic Hepatitis C To Allow The Initiation And Maintenance Of Interferon-Based Therapy. Promacta Should Be Used Only In Patients With Chronic Hepatitis C Whose Degree Of Thrombocytopenia Prevents The Initiation Of Interferon-Based Therapy Or Limits The Ability To Maintain Interferon-Based Therapy. 1.3 Treatment Of Severe Aplastic Anemia Promacta Is Indicated For The Treatment Of Patients With Severe Aplastic Anemia Who Have Had An Insufficient Response To Immunosuppressive Therapy. 1.4 Limitations Of Use Promacta Is Not Indicated For The Treatment Of Patients With Myelodysplastic Syndromes (mds) [see Warnings And Precautions (5.3)]. Safety And Efficacy Have Not Been Established In Combination With Direct-Acting Antiviral Agents Used Without Interferon For Treatment Of Chronic Hepatitis C Infection.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Eltrombopag Olamine ELTROMBOPAG OLAMINE ZINC8214617

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