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LABELS · 241b0b4f-eca3-be93-e063-6394a90a5789

Aphexda

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
2024-10-10
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. ( 1 )
Full extracted label fields
application numbers
  1. NDA217159
boxed warning exact
    brand names
    1. Aphexda
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7cdc584-ebf0-a68e-e053-6294a90a9ea9
    generic names
    1. MOTIXAFORTIDE
    id
    241b0b4f-eca3-be93-e063-6394a90a5789
    indications and usage exact
    1. 1 INDICATIONS AND USAGE APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. BioLineRx USA Inc
      matched search terms
      1. myeloma
      package ndcs
      1. 82737-073-01
      product ndcs
      1. 82737-073
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2664901
        2. 2664906
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22241b0b4f-eca3-be93-e063-6394a90a5789%22
        spl effective date
        2024-10-10
        spl effective time
        20241010
        spl set id
        f7cdc584-ebf0-a68e-e053-6294a90a9ea9
        spl version
        2
        substance names
        1. MOTIXAFORTIDE ACETATE
        uniis
        1. 3ZPX60DV8A
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          NDA217159
          payload
          all indexed label documents
          1. Appl No
            217159
            Application Docs Date
            2023-09-13 00:00:00
            Application Docs ID
            75441
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            217159
            Application Docs Date
            2026-03-12 00:00:00
            Application Docs ID
            85360
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            217159
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2023-09-08 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            217159
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2026-03-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA217159
          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
          2026-03-11
          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
            217159
            Application Docs Date
            2026-03-12 00:00:00
            Application Docs ID
            85360
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          official application record
          Appl No
          217159
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          AYRMID PHARMA
          openfda application present
          true
          products
          1. Active Ingredient
            MOTIXAFORTIDE ACETATE
            Appl No
            217159
            Drug Name
            APHEXDA
            Form
            POWDER;SUBCUTANEOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 62MG BASE/VIAL
            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. NDA217159
        brand names
        1. Aphexda
        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
        436
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous
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        start
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        current approval status
        not_reconciled
        duplicate text group
        dup-73799e379cb585b191b1
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. MOTIXAFORTIDE
        id
        ind-span-f24aeb4537331bf633a1
        label id
        241b0b4f-eca3-be93-e063-6394a90a5789
        positive predicate support span
        end
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        end exclusive
        true
        exact text
        is indicated
        label id
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        offset unit
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        source field
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        source text sha256
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        start
        32
        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
          kind
          regimen
          polarity
          not_inferred
          span
          end
          224
          end exclusive
          true
          exact text
          in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multi
          label id
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          source text sha256
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        regulatory links
          schema version
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          source defined aliases
            source span
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            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
            label id
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            source text sha256
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            start
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22241b0b4f-eca3-be93-e063-6394a90a5789%22
            spl effective date
            2024-10-10
            spl set id
            f7cdc584-ebf0-a68e-e053-6294a90a9ea9
            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. NDA217159
            brand names
            1. Aphexda
            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
            493
            end exclusive
            true
            exact text
            dicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. ( 1 )
            label id
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            offset unit
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            source field
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            source text sha256
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            start
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            current approval status
            not_reconciled
            duplicate text group
            dup-75dbd3cfd34c61ea4897
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. MOTIXAFORTIDE
            id
            ind-span-a6e98e80882ea4a28b4b
            label id
            241b0b4f-eca3-be93-e063-6394a90a5789
            positive predicate support span
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            295
            end exclusive
            true
            exact text
            is indicated
            label id
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            offset unit
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            source field
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            source text sha256
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            start
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            qualifier mentions
            1. context exact
              APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
              kind
              regimen
              polarity
              not_inferred
              span
              end
              475
              end exclusive
              true
              exact text
              in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multi
              label id
              241b0b4f-eca3-be93-e063-6394a90a5789
              offset unit
              unicode_code_points
              source array index
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              source field
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              source text sha256
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            regulatory links
              schema version
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              source defined aliases
                source span
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                487
                end exclusive
                true
                exact text
                APHEXDA, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
                label id
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                offset unit
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                source field
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                source text sha256
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                source url
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                spl effective date
                2024-10-10
                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
                tumor_directed_candidate
                Passage 3 · unclassified context
                application numbers
                1. NDA217159
                brand names
                1. Aphexda
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                493
                end exclusive
                true
                exact text
                dicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. ( 1 )
                label id
                241b0b4f-eca3-be93-e063-6394a90a5789
                offset unit
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                current approval status
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                duplicate text group
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                extraction review status
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                generic names
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                id
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                label id
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                positive predicate support span
                Source null
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                  regulatory links
                    schema version
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                      ( 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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                      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
                      unclear

                      Preserved source evidence · Not medical advice