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LABELS · ba468eca-fb47-497b-8aed-a1576249ea6a

Plerixafor

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
2025-11-19
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Plerixafor 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). Plerixafor, 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. Plerixafor
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d670cb4-163e-498c-b5fa-c193ea9d55c0
    generic names
    1. PLERIXAFOR
    id
    ba468eca-fb47-497b-8aed-a1576249ea6a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Plerixafor 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). Plerixafor, 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. Fresenius Kabi Usa, LLC
      matched search terms
      1. lymphoma
      2. myeloma
      package ndcs
      1. 65219-284-12
      product ndcs
      1. 65219-284
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 828700
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.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
        600
        total
        830
        sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        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=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22ba468eca-fb47-497b-8aed-a1576249ea6a%22
        spl effective date
        2025-11-19
        spl effective time
        20251119
        spl set id
        5d670cb4-163e-498c-b5fa-c193ea9d55c0
        spl version
        12
        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. Plerixafor
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        475
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Plerixafor 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). Plerixafor, 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 autologo
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        generic names
        1. PLERIXAFOR
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        exact text
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        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE Plerixafor 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
          polarity
          not_inferred
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          227
          end exclusive
          true
          exact text
          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 batch sha256
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          source defined aliases
          1. abbreviation
            MM
            definition exact
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            definition span
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            274
            end exclusive
            true
            exact text
            multiple myeloma (MM)
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          exact text
          1 INDICATIONS AND USAGE Plerixafor 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
          2025-11-19
          spl set id
          5d670cb4-163e-498c-b5fa-c193ea9d55c0
          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
          1. NDA022311
          brand names
          1. Plerixafor
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
          pending
          content role
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          context span
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          560
          end exclusive
          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). Plerixafor, 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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          qualifier mentions
          1. context exact
            erixafor, 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.
            kind
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            not_inferred
            span
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            517
            end exclusive
            true
            exact text
            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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              exact text
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            Plerixafor, 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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            source url
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            Source null
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            Source null
            limitations
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            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
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            Passage 3 · unclassified context
            application numbers
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            end exclusive
            true
            exact text
            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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            id
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            label id
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            positive predicate support span
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              regulatory links
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                source batch sha256
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                source defined aliases
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                  start
                  253
                source span
                end
                560
                end exclusive
                true
                exact text
                ( 1 )
                label id
                ba468eca-fb47-497b-8aed-a1576249ea6a
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                d1190bb3d0e78380d260db0cc4dc8c8659023c4df6fd0acfbeb1f37f66a2e126
                start
                555
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22ba468eca-fb47-497b-8aed-a1576249ea6a%22
                spl effective date
                2025-11-19
                spl set id
                5d670cb4-163e-498c-b5fa-c193ea9d55c0
                spl version
                12
                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