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LABELS · 184bc16b-40f1-4fd3-a70b-17bbb44eac21

NINLARO

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
2026-08-11
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials [see Warnings and Precautions (5.9) and Clinical Studies (14.2 , 14.3) ] .
Full extracted label fields
application numbers
  1. NDA208462
boxed warning exact
    brand names
    1. NINLARO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038f2461-834b-4488-9ebd-863c83eef5a7
    generic names
    1. IXAZOMIB
    id
    184bc16b-40f1-4fd3-a70b-17bbb44eac21
    indications and usage exact
    1. 1 INDICATIONS AND USAGE NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials [see Warnings and Precautions (5.9) and Clinical Studies (14.2 , 14.3) ] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Takeda Pharmaceuticals America, Inc.
      matched search terms
      1. myeloma
      package ndcs
      1. 63020-400-03
      2. 63020-400-02
      3. 63020-400-01
      4. 63020-390-03
      5. 63020-390-02
      6. 63020-390-01
      7. 63020-230-03
      8. 63020-230-02
      9. 63020-230-01
      product ndcs
      1. 63020-230
      2. 63020-400
      3. 63020-390
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1723757
        2. 1723763
        3. 1723765
        4. 1723767
        5. 1723770
        6. 1723772
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
        0
        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=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22184bc16b-40f1-4fd3-a70b-17bbb44eac21%22
        spl effective date
        2026-08-11
        spl effective time
        20260811
        spl set id
        038f2461-834b-4488-9ebd-863c83eef5a7
        spl version
        18
        substance names
        1. IXAZOMIB CITRATE
        uniis
        1. 46CWK97Z3K
        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
          NDA208462
          payload
          all indexed label documents
          1. Appl No
            208462
            Application Docs Date
            2015-11-20 00:00:00
            Application Docs ID
            40634
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            208462
            Application Docs Date
            2016-12-01 00:00:00
            Application Docs ID
            45998
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            208462
            Application Docs Date
            2020-02-27 00:00:00
            Application Docs ID
            61981
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          4. Appl No
            208462
            Application Docs Date
            2020-09-15 00:00:00
            Application Docs ID
            64578
            Application Docs Title
            0
            Application Docs Type ID
            2
            Application Docs URL
            http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf
            Submission No
            8
            Submission Type
            SUPPL
          5. Appl No
            208462
            Application Docs Date
            2020-09-15 00:00:00
            Application Docs ID
            64579
            Application Docs Title
            0
            Application Docs Type ID
            2
            Application Docs URL
            http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208462Orig1s007, s008lbl.pdf
            Submission No
            7
            Submission Type
            SUPPL
          6. Appl No
            208462
            Application Docs Date
            2021-03-11 00:00:00
            Application Docs ID
            66740
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          7. Appl No
            208462
            Application Docs Date
            2022-04-29 00:00:00
            Application Docs ID
            70855
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          8. Appl No
            208462
            Application Docs Date
            2022-04-29 00:00:00
            Application Docs ID
            70856
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          9. Appl No
            208462
            Application Docs Date
            2024-03-04 00:00:00
            Application Docs ID
            77691
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          10. Appl No
            208462
            Application Docs Date
            2024-07-05 00:00:00
            Application Docs ID
            78982
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            208462
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2015-11-20 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2016-11-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2020-02-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2020-09-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2020-09-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2021-03-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2022-04-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2022-04-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2024-03-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            208462
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2024-07-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA208462
          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
          2024-07-01
          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
            208462
            Application Docs Date
            2024-07-05 00:00:00
            Application Docs ID
            78982
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          official application record
          Appl No
          208462
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          TAKEDA PHARMS USA
          openfda application present
          true
          products
          1. Active Ingredient
            IXAZOMIB CITRATE
            Appl No
            208462
            Drug Name
            NINLARO
            Form
            CAPSULE;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 2.3MG BASE
            marketing status
            1. Prescription
          2. Active Ingredient
            IXAZOMIB CITRATE
            Appl No
            208462
            Drug Name
            NINLARO
            Form
            CAPSULE;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            EQ 3MG BASE
            marketing status
            1. Prescription
          3. Active Ingredient
            IXAZOMIB CITRATE
            Appl No
            208462
            Drug Name
            NINLARO
            Form
            CAPSULE;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 4MG BASE
            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. NDA208462
        brand names
        1. NINLARO
        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
        395
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 )
        label id
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        id
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        1. context exact
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          end exclusive
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        2. context exact
          1 INDICATIONS AND USAGE NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
          kind
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          not_inferred
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          end exclusive
          true
          exact text
          in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
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            1 INDICATIONS AND USAGE NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
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            source url
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            spl effective date
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            spl set id
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            structured fields status
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            Source null
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            biomarker and test
            Source null
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            Source null
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            tumor_directed_candidate
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            application numbers
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            1 INDICATIONS AND USAGE NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlle
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                NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
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                Source null
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                Source null
                biomarker and test
                Source null
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                Source null
                limitations
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                Source null
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                Source null
                regimen
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                Source null
                use intent
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