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LABELS · 8d803fd6-c715-4d8b-818b-bd5d537c3d60

ACTIMMUNE

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
2026-03-30
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) ( 1 ) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO) ( 1 )
Full extracted label fields
application numbers
  1. BLA103836
boxed warning exact
    brand names
    1. ACTIMMUNE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d0b1256-1981-4519-94f4-a4a2f98bd8a3
    generic names
    1. INTERFERON GAMMA-1B
    id
    8d803fd6-c715-4d8b-818b-bd5d537c3d60
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) ( 1 ) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO) ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Horizon Therapeutics USA, Inc.
      matched search terms
      1. malignant
      package ndcs
      1. 75987-111-10
      2. 75987-111-11
      product ndcs
      1. 75987-111
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 240448
        2. 751970
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00500.json
        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
        limit
        100
        skip
        500
        total
        830
        sha256
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        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
        source url
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        spl effective date
        2026-03-30
        spl effective time
        20260330
        spl set id
        5d0b1256-1981-4519-94f4-a4a2f98bd8a3
        spl version
        11
        substance names
        1. INTERFERON GAMMA-1B
        uniis
        1. 21K6M2I7AG
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
        3. individual_indications_not_split_or_reconciled
        Drugs@FDA application source records
        1. application number
          BLA103836
          payload
          all indexed label documents
          1. Appl No
            103836
            Application Docs Date
            2015-08-28 00:00:00
            Application Docs ID
            18670
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5182
            Submission Type
            SUPPL
          2. Appl No
            103836
            Application Docs Date
            2004-12-06 00:00:00
            Application Docs ID
            39727
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5050
            Submission Type
            SUPPL
          3. Appl No
            103836
            Application Docs Date
            2007-02-23 00:00:00
            Application Docs ID
            39728
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5098
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            103836
            Review Priority
            UNKNOWN
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1999-02-25 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            103836
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            1001
            Submission Status
            AP
            Submission Status Date
            2000-02-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            103836
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5017
            Submission Status
            AP
            Submission Status Date
            2003-05-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            103836
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            5033
            Submission Status
            AP
            Submission Status Date
            2004-03-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            103836
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5050
            Submission Status
            AP
            Submission Status Date
            2004-11-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            103836
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5071
            Submission Status
            AP
            Submission Status Date
            2005-09-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            103836
            Review Priority
            Submission Class Code ID
            6
            Submission No
            5098
            Submission Status
            AP
            Submission Status Date
            2007-01-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            103836
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5182
            Submission Status
            AP
            Submission Status Date
            2015-08-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA103836
          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
          2015-08-27
          latest label selection rule
          max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
          latest posted label documents
          1. Appl No
            103836
            Application Docs Date
            2015-08-28 00:00:00
            Application Docs ID
            18670
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5182
            Submission Type
            SUPPL
          official application record
          Appl No
          103836
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          HORIZON THERAPEUTICS IRELAND DAC
          openfda application present
          true
          products
          1. Active Ingredient
            INTERFERON GAMMA-1B
            Appl No
            103836
            Drug Name
            ACTIMMUNE
            Form
            VIAL; SINGLE-USE
            Product No
            001
            Reference Drug
            0
            Reference Standard
            Strength
            100UG/0.5ML
            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. BLA103836
        brand names
        1. ACTIMMUNE
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        361
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and seve
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        generic names
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        qualifier mentions
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              1 INDICATIONS AND USAGE ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD).
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              spl effective date
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              spl set id
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              Passage 2 · positive indication candidate
              application numbers
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              clinical review status
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              exact text
              1 INDICATIONS AND USAGE ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) ( 1 ) Delaying time to disease progressio
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                    exact text
                    ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).
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                    source url
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                    spl effective date
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                    spl set id
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                    spl version
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                    structured fields status
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                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
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                    Passage 3 · positive indication candidate
                    application numbers
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                    clinical review status
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                    exact text
                    rity of serious infections associated with Chronic Granulomatous Disease (CGD). ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO). ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) ( 1 ) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO) ( 1 )
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                    is an interferon gamma indicated
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                          ACTIMMUNE is an interferon gamma indicated for: Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) ( 1 ) Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO) ( 1 )
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                          source url
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                          spl effective date
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                          spl set id
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                          Source null
                          approval pathway
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                          biomarker and test
                          Source null
                          disease stage
                          Source null
                          limitations
                          Source null
                          line
                          Source null
                          prior therapy
                          Source null
                          regimen
                          Source null
                          tumor histology
                          Source null
                          use intent
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                          Preserved source evidence · Not medical advice