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LABELS · 3ec2a1ae-4ca9-43b3-a3e2-2b79c2a34172

FERRIPROX

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-05-22
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: AGRANULOCYTOSIS AND NEUTROPENIA FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions ( 5.1 )] Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor regularly while on therapy. [see Warnings and Precautions ( 5.1 )] Interrupt FERRIPROX therapy if neutropenia develops. [see Warnings and Precautions ( 5.1 )] Interrupt FERRIPROX if infection develops, and monitor the ANC more frequently. [see Warnings and Precautions ( 5.1 )] Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. [see Warnings and Precautions ( 5.1 )] WARNING: AGRANULOCYTOSIS AND NEUTROPENIA See full prescribing information for complete boxed warning. FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. ( 5.1 ) Measure the absolute neutrophil count (ANC) before starting FERRIPROX and monitor regularly while on therapy. ( 5.1 ) Interrupt FERRIPROX therapy if neutropenia develops. ( 5.1 ) Interrupt FERRIPROX if infection develops and monitor the ANC more frequently. ( 5.1 ) Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE FERRIPROX Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. FERRIPROX Oral Solution is an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. ( 1 ) Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.
Full extracted label fields
application numbers
  1. NDA208030
boxed warning exact
  1. WARNING: AGRANULOCYTOSIS AND NEUTROPENIA FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions ( 5.1 )] Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor regularly while on therapy. [see Warnings and Precautions ( 5.1 )] Interrupt FERRIPROX therapy if neutropenia develops. [see Warnings and Precautions ( 5.1 )] Interrupt FERRIPROX if infection develops, and monitor the ANC more frequently. [see Warnings and Precautions ( 5.1 )] Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. [see Warnings and Precautions ( 5.1 )] WARNING: AGRANULOCYTOSIS AND NEUTROPENIA See full prescribing information for complete boxed warning. FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. ( 5.1 ) Measure the absolute neutrophil count (ANC) before starting FERRIPROX and monitor regularly while on therapy. ( 5.1 ) Interrupt FERRIPROX therapy if neutropenia develops. ( 5.1 ) Interrupt FERRIPROX if infection develops and monitor the ANC more frequently. ( 5.1 ) Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. ( 5.1 )
brand names
  1. FERRIPROX
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f057cf4d-b06f-4fbd-aa2e-68c5e4d8a846
generic names
  1. DEFERIPRONE
id
3ec2a1ae-4ca9-43b3-a3e2-2b79c2a34172
indications and usage exact
  1. 1 INDICATIONS AND USAGE FERRIPROX Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. FERRIPROX Oral Solution is an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. ( 1 ) Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Chiesi USA, Inc.
    matched search terms
    1. myelodysplastic
    package ndcs
    1. 10122-101-50
    product ndcs
    1. 10122-101
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Warnings and Precautions, Agranulocytosis and Neutropenia ( 5.1 ) 3/2025
    record type
    complete_spl_indications_section_candidate
    routes
    1. ORAL
    rxcuis
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    2. 1716268
    source batch
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    meta
    disclaimer
    Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
    last updated
    2026-09-09
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    spl effective date
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    spl effective time
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    substance names
    1. DEFERIPRONE
    uniis
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    2. spl_text_not_verified_identical_to_latest_approved_label
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    1. application number
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      payload
      all indexed label documents
      1. Appl No
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        Application Docs Date
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        Application Docs ID
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        Application Docs Title
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        Application Docs Type ID
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        Submission No
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        Submission Type
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      2. Appl No
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        Application Docs Date
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        Application Docs ID
        53793
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        2
        Submission Type
        SUPPL
      3. Appl No
        208030
        Application Docs Date
        2020-02-21 00:00:00
        Application Docs ID
        61936
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      4. Appl No
        208030
        Application Docs Date
        2021-05-03 00:00:00
        Application Docs ID
        67316
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
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      5. Appl No
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        Application Docs Date
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        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      6. Appl No
        208030
        Application Docs Date
        2025-03-27 00:00:00
        Application Docs ID
        81756
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        208030
        Review Priority
        STANDARD
        Submission Class Code ID
        12
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2015-09-09 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        208030
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2018-04-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        208030
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2020-02-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        208030
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2021-04-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        208030
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2021-11-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        208030
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2025-03-26 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
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      approval interpretation
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      has approved submission record
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      latest posted label documents
      1. Appl No
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        Application Docs Date
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        Application Docs ID
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        Application Docs Title
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        Application Docs Type ID
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        Submission No
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      official application record
      Appl No
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      Appl Public Notes
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      NDA
      Sponsor Name
      CHIESI
      openfda application present
      true
      products
      1. Active Ingredient
        DEFERIPRONE
        Appl No
        208030
        Drug Name
        FERRIPROX
        Form
        SOLUTION;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        100MG/ML
        marketing status
        1. Prescription
      2. Active Ingredient
        DEFERIPRONE
        Appl No
        208030
        Drug Name
        FERRIPROX
        Form
        SOLUTION;ORAL
        Product No
        002
        Reference Drug
        1
        Reference Standard
        0
        Strength
        80MG/ML
        marketing status
        1. Discontinued

    Source passages and status connections

    Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

    Passage 1 · positive indication candidate
    application numbers
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    brand names
    1. FERRIPROX
    classification reasons
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    2. no_tumor_directed_keyword_in_positive_statement
    clinical review status
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    content role
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    exact text
    1 INDICATIONS AND USAGE FERRIPROX Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. FERRIPROX Oral Solution is an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell
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        1 INDICATIONS AND USAGE FERRIPROX Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.
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        Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. FERRIPROX Oral Solution is an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. ( 1 ) Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blac
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            FERRIPROX Oral Solution is an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.
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