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LABELS · f6d7984f-011e-4a3f-bcf5-6a5b2b6ef2f9

FERRIPROX

Open original source → · Download preserved record

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
2026-01-28
Captured
2026-09-09T23:38:04.335995+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. • 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 Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitation s 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. FERRIPROX Tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. ( 1 ) Limitation s 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. NDA021825
  2. NDA212269
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. • 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=946718ff-df43-1baa-74d1-e5bcfbe8ad86
generic names
  1. DEFERIPRONE
id
f6d7984f-011e-4a3f-bcf5-6a5b2b6ef2f9
indications and usage exact
  1. 1 INDICATIONS AND USAGE FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitation s 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. FERRIPROX Tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. ( 1 ) Limitation s 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. 10122-104-01
    2. 10122-104-05
    3. 10122-103-05
    4. 10122-100-11
    5. 10122-100-12
    product ndcs
    1. 10122-103
    2. 10122-104
    3. 10122-100
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Warnings and Precautions, Agranulocytosis and Neutropenia ( 5.1 ) 3/2025
    record type
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    routes
    1. ORAL
    rxcuis
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    2. 1190357
    3. 2180997
    4. 2180999
    5. 2685014
    6. 2685015
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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
    results
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    sha256
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    url
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    spl effective date
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    spl effective time
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    spl version
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    substance names
    1. DEFERIPRONE
    uniis
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      payload
      all indexed label documents
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        Application Docs Date
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        Application Docs ID
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        Submission Type
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        Submission Type
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        Application Docs ID
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        Application Docs Title
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        Application Docs Type ID
        2
        Submission No
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        Submission Type
        SUPPL
      4. Appl No
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        Application Docs Date
        2019-07-30 00:00:00
        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
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      5. Appl No
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        Application Docs Date
        2020-02-21 00:00:00
        Application Docs ID
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        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      6. Appl No
        021825
        Application Docs Date
        2021-05-03 00:00:00
        Application Docs ID
        67312
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        0
        Application Docs Type ID
        2
        Submission No
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        Submission Type
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      7. Appl No
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        Application Docs Date
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        Application Docs ID
        69443
        Application Docs Title
        0
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        2
        Submission No
        10
        Submission Type
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      8. Appl No
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        Application Docs ID
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        Submission No
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        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      2. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
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        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      3. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2021-04-30 00:00:00
        Submission Type
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        Submissions Public Notes
      4. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
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        Submission Status
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        Submission Status Date
        2020-02-20 00:00:00
        Submission Type
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        Submissions Public Notes
      5. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
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        Submission Status
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        Submissions Public Notes
      6. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
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        Submission Status
        AP
        Submission Status Date
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        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        021825
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2012-11-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        021825
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2012-04-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        021825
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        1
        Submission Status
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        Submission Status Date
        2011-10-14 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
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      approval interpretation
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      current indication status
      not_reconciled
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      latest approved submission date
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      latest label selection rule
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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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      Appl No
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      true
      products
      1. Active Ingredient
        DEFERIPRONE
        Appl No
        021825
        Drug Name
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        Form
        TABLET;ORAL
        Product No
        001
        Reference Drug
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        Reference Standard
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        marketing status
        1. Discontinued
      2. Active Ingredient
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        Appl No
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        Drug Name
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        Product No
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        Reference Drug
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        Reference Standard
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        marketing status
        1. Prescription
    2. application number
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      payload
      all indexed label documents
      1. Appl No
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        Application Docs Date
        2020-05-20 00:00:00
        Application Docs ID
        63165
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
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        Submission Type
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      2. Appl No
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        Submission No
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      1. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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        Submission Status
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        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      2. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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        Submission Status
        AP
        Submission Status Date
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        Submission Type
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      3. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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      4. Appl No
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        Submission No
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        Submissions Public Notes
      application number
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      approval interpretation
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      current indication status
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      has approved submission record
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      latest approved submission date
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      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
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        Appl No
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        Drug Name
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        Product No
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        Reference Drug
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        Reference Standard
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        Strength
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        marketing status
        1. Prescription

    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
    1. NDA021825
    2. NDA212269
    brand names
    1. FERRIPROX
    classification reasons
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    exact text
    1 INDICATIONS AND USAGE FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitation s 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 Blackfa
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        1 INDICATIONS AND USAGE FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.
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        Source null
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        Passage 2 · unclassified context
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        IPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitation s 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. FERRIPROX
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