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LABELS · fec4102e-2c66-433f-ab6c-7f420b4c3a86

Mozobil

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
2025-09-22
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma. ( 1 )
Full extracted label fields
application numbers
  1. NDA022311
boxed warning exact
    brand names
    1. Mozobil
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0ed08d2b-5051-46b2-aa37-1d6275bf9003
    generic names
    1. PLERIXAFOR
    id
    fec4102e-2c66-433f-ab6c-7f420b4c3a86
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Sanofi-Aventis U.S. LLC
      matched search terms
      1. lymphoma
      2. myeloma
      package ndcs
      1. 0024-5862-01
      product ndcs
      1. 0024-5862
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 828700
        2. 828703
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00800.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
        800
        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=800&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22fec4102e-2c66-433f-ab6c-7f420b4c3a86%22
        spl effective date
        2025-09-22
        spl effective time
        20250922
        spl set id
        0ed08d2b-5051-46b2-aa37-1d6275bf9003
        spl version
        24
        substance names
        1. PLERIXAFOR
        uniis
        1. S915P5499N
        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
          NDA022311
          payload
          all indexed label documents
          1. Appl No
            022311
            Application Docs Date
            2009-01-02 00:00:00
            Application Docs ID
            17225
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            022311
            Application Docs Date
            2014-12-10 00:00:00
            Application Docs ID
            17226
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          3. Appl No
            022311
            Application Docs Date
            2010-06-15 00:00:00
            Application Docs ID
            38552
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          4. Appl No
            022311
            Application Docs Date
            2013-06-11 00:00:00
            Application Docs ID
            38553
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          5. Appl No
            022311
            Application Docs Date
            2015-08-06 00:00:00
            Application Docs ID
            38554
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          6. Appl No
            022311
            Application Docs Date
            2017-12-04 00:00:00
            Application Docs ID
            50599
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            18
            Submission Type
            SUPPL
          7. Appl No
            022311
            Application Docs Date
            2019-05-31 00:00:00
            Application Docs ID
            58907
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          8. Appl No
            022311
            Application Docs Date
            2020-08-20 00:00:00
            Application Docs ID
            64326
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            22
            Submission Type
            SUPPL
          9. Appl No
            022311
            Application Docs Date
            2023-09-25 00:00:00
            Application Docs ID
            75562
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            022311
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2023-09-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            022311
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            2020-08-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            022311
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2019-05-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            022311
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2017-12-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            022311
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2016-05-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            022311
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2015-08-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            022311
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2014-12-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            022311
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2013-11-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            022311
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2013-06-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            022311
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2013-02-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            022311
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2010-06-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            022311
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2008-12-15 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA022311
          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
          2023-09-21
          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
            022311
            Application Docs Date
            2023-09-25 00:00:00
            Application Docs ID
            75562
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          official application record
          Appl No
          022311
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          GENZYME
          openfda application present
          true
          products
          1. Active Ingredient
            PLERIXAFOR
            Appl No
            022311
            Drug Name
            MOZOBIL
            Form
            SOLUTION;SUBCUTANEOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            24MG/1.2ML (20MG/ML)
            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. NDA022311
        brand names
        1. Mozobil
        classification reasons
        1. explicit_positive_indication_predicate
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        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        472
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous
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        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).
          kind
          regimen
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          224
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          true
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          in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Ho
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        regulatory links
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          source defined aliases
          1. abbreviation
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            definition exact
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            definition span
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            true
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            multiple myeloma (MM)
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          1 INDICATIONS AND USAGE Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).
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          source url
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          spl effective date
          2025-09-22
          spl set id
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          spl version
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          structured fields status
          not_extracted_no_values_inferred_from_mentions
          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
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
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          brand names
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          classification reasons
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          clinical review status
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          true
          exact text
          im to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma. ( 1 )
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            in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Ho
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            Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.
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            Passage 3 · unclassified context
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            th filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma. ( 1 )
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                  start
                  250
                source span
                end
                554
                end exclusive
                true
                exact text
                ( 1 )
                label id
                fec4102e-2c66-433f-ab6c-7f420b4c3a86
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                131ec4eed38c77488a03c122498a1c46a366b3d68d881a97f0da04f63e0369b9
                start
                549
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22fec4102e-2c66-433f-ab6c-7f420b4c3a86%22
                spl effective date
                2025-09-22
                spl set id
                0ed08d2b-5051-46b2-aa37-1d6275bf9003
                spl version
                24
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                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
                unclear

                Preserved source evidence · Not medical advice