Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 08c46856-2700-4885-ba5d-dced9d8056e1

ISTODAX

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
2023-01-31
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 ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
Full extracted label fields
application numbers
  1. NDA022393
boxed warning exact
    brand names
    1. ISTODAX
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=03b39d40-90fe-11df-9de6-0002a5d5c51b
    generic names
    1. ROMIDEPSIN
    id
    08c46856-2700-4885-ba5d-dced9d8056e1
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Celgene Corporation
      matched search terms
      1. lymphoma
      package ndcs
      1. 59572-983-01
      2. 59572-961-10
      3. 59572-972-02
      4. 59572-984-01
      5. 59572-962-10
      6. 59572-973-02
      product ndcs
      1. 59572-984
      2. 59572-983
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage, Peripheral T-cell Lymphoma (1.2) Removed 7/2021
      record type
      complete_spl_indications_section_candidate
      routes
        rxcuis
        1. 877513
        2. 877516
        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
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        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%2208c46856-2700-4885-ba5d-dced9d8056e1%22
        spl effective date
        2023-01-31
        spl effective time
        20230131
        spl set id
        03b39d40-90fe-11df-9de6-0002a5d5c51b
        spl version
        21
        substance names
          uniis
            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
              NDA022393
              payload
              all indexed label documents
              1. Appl No
                022393
                Application Docs Date
                2011-06-16 00:00:00
                Application Docs ID
                17306
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                4
                Submission Type
                SUPPL
              2. Appl No
                022393
                Application Docs Date
                2013-06-18 00:00:00
                Application Docs ID
                17307
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                11
                Submission Type
                SUPPL
              3. Appl No
                022393
                Application Docs Date
                2014-10-16 00:00:00
                Application Docs ID
                17308
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                13
                Submission Type
                SUPPL
              4. Appl No
                022393
                Application Docs Date
                2009-11-06 00:00:00
                Application Docs ID
                38648
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                ORIG
              5. Appl No
                022393
                Application Docs Date
                2011-04-15 00:00:00
                Application Docs ID
                38649
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                1
                Submission Type
                SUPPL
              6. Appl No
                022393
                Application Docs Date
                2011-09-30 00:00:00
                Application Docs ID
                38650
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                6
                Submission Type
                SUPPL
              7. Appl No
                022393
                Application Docs Date
                2016-07-28 00:00:00
                Application Docs ID
                38651
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                14
                Submission Type
                SUPPL
              8. Appl No
                022393
                Application Docs Date
                2019-07-09 00:00:00
                Application Docs ID
                59287
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                15
                Submission Type
                SUPPL
              9. Appl No
                022393
                Application Docs Date
                2021-05-27 00:00:00
                Application Docs ID
                67615
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                16
                Submission Type
                SUPPL
              10. Appl No
                022393
                Application Docs Date
                2021-08-03 00:00:00
                Application Docs ID
                68273
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                17
                Submission Type
                SUPPL
              all submission records
              1. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                7
                Submission No
                1
                Submission Status
                AP
                Submission Status Date
                2009-11-05 00:00:00
                Submission Type
                ORIG
                Submissions Public Notes
              2. Appl No
                022393
                Review Priority
                UNKNOWN
                Submission Class Code ID
                3
                Submission No
                1
                Submission Status
                AP
                Submission Status Date
                2011-04-12 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              3. Appl No
                022393
                Review Priority
                PRIORITY
                Submission Class Code ID
                2
                Submission No
                4
                Submission Status
                AP
                Submission Status Date
                2011-06-16 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              4. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                6
                Submission Status
                AP
                Submission Status Date
                2011-09-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              5. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                11
                Submission Status
                AP
                Submission Status Date
                2013-06-13 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              6. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                4
                Submission No
                12
                Submission Status
                AP
                Submission Status Date
                2013-09-13 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              7. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                2
                Submission No
                13
                Submission Status
                AP
                Submission Status Date
                2014-10-15 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              8. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                14
                Submission Status
                AP
                Submission Status Date
                2016-07-27 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              9. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                15
                Submission Status
                AP
                Submission Status Date
                2018-11-27 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              10. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                3
                Submission No
                16
                Submission Status
                AP
                Submission Status Date
                2021-03-24 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              11. Appl No
                022393
                Review Priority
                STANDARD
                Submission Class Code ID
                2
                Submission No
                17
                Submission Status
                AP
                Submission Status Date
                2021-07-30 00:00:00
                Submission Type
                SUPPL
                Submissions Public Notes
              application number
              NDA022393
              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
              2021-07-30
              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
                022393
                Application Docs Date
                2021-08-03 00:00:00
                Application Docs ID
                68273
                Application Docs Title
                0
                Application Docs Type ID
                2
                Submission No
                17
                Submission Type
                SUPPL
              official application record
              Appl No
              022393
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              BRISTOL-MYERS
              openfda application present
              true
              products
              1. Active Ingredient
                ROMIDEPSIN
                Appl No
                022393
                Drug Name
                ISTODAX
                Form
                POWDER;INTRAVENOUS
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                10MG/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. NDA022393
            brand names
            1. ISTODAX
            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
            364
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
            label id
            08c46856-2700-4885-ba5d-dced9d8056e1
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-0eab4ec1202514cc8d9f
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. ROMIDEPSIN
            id
            ind-span-ab156a79a0a701e01637
            label id
            08c46856-2700-4885-ba5d-dced9d8056e1
            positive predicate support span
            end
            44
            end exclusive
            true
            exact text
            is indicated
            label id
            08c46856-2700-4885-ba5d-dced9d8056e1
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
            start
            32
            qualifier mentions
            1. context exact
              ed for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
              kind
              age
              polarity
              not_inferred
              span
              end
              116
              end exclusive
              true
              exact text
              adult patients
              label id
              08c46856-2700-4885-ba5d-dced9d8056e1
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
              start
              102
            2. context exact
              tment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
              kind
              prior_therapy_or_line
              polarity
              not_inferred
              span
              end
              170
              end exclusive
              true
              exact text
              who have received at least one prior systemic therapy
              label id
              08c46856-2700-4885-ba5d-dced9d8056e1
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
              start
              117
            regulatory links
              schema version
              0.1.0
              source batch sha256
              0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
              source defined aliases
                source span
                end
                171
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
                label id
                08c46856-2700-4885-ba5d-dced9d8056e1
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
                start
                0
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%2208c46856-2700-4885-ba5d-dced9d8056e1%22
                spl effective date
                2023-01-31
                spl set id
                03b39d40-90fe-11df-9de6-0002a5d5c51b
                spl version
                21
                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. NDA022393
                brand names
                1. ISTODAX
                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
                364
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
                label id
                08c46856-2700-4885-ba5d-dced9d8056e1
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
                start
                0
                current approval status
                not_reconciled
                duplicate text group
                dup-e28e4dfdfdfc172fce1d
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. ROMIDEPSIN
                id
                ind-span-e9eff600e030e28df9ae
                label id
                08c46856-2700-4885-ba5d-dced9d8056e1
                positive predicate support span
                end
                231
                end exclusive
                true
                exact text
                is a histone deacetylase (HDAC) inhibitor indicated
                label id
                08c46856-2700-4885-ba5d-dced9d8056e1
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
                start
                180
                qualifier mentions
                1. context exact
                  ed for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 )
                  kind
                  age
                  polarity
                  not_inferred
                  span
                  end
                  303
                  end exclusive
                  true
                  exact text
                  adult patients
                  label id
                  08c46856-2700-4885-ba5d-dced9d8056e1
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
                  start
                  289
                2. context exact
                  tment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
                  kind
                  prior_therapy_or_line
                  polarity
                  not_inferred
                  span
                  end
                  363
                  end exclusive
                  true
                  exact text
                  who have received at least one prior systemic therapy ( 1 )
                  label id
                  08c46856-2700-4885-ba5d-dced9d8056e1
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
                  start
                  304
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                  source defined aliases
                    source span
                    end
                    364
                    end exclusive
                    true
                    exact text
                    ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
                    label id
                    08c46856-2700-4885-ba5d-dced9d8056e1
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    55da4058e9ea81cf4549076da2c7197312777666a57d75ec84896630c7569107
                    start
                    172
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%2208c46856-2700-4885-ba5d-dced9d8056e1%22
                    spl effective date
                    2023-01-31
                    spl set id
                    03b39d40-90fe-11df-9de6-0002a5d5c51b
                    spl version
                    21
                    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

                    Preserved source evidence · Not medical advice