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LABELS · 889accaa-7f62-4da4-84ea-80ecfb144209

PEDMARK

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
2025-10-27
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred. PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. ( 1 ) Limitations of Use: The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
Full extracted label fields
application numbers
  1. NDA212937
boxed warning exact
    brand names
    1. PEDMARK
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f98c7076-2a7b-4fd7-ab90-eed5e9137bae
    generic names
    1. SODIUM THIOSULFATE
    id
    889accaa-7f62-4da4-84ea-80ecfb144209
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred. PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. ( 1 ) Limitations of Use: The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Fennec Pharmaceuticals Inc.
      matched search terms
      1. tumors
      package ndcs
      1. 73077-010-01
      product ndcs
      1. 73077-010
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 2618749
        2. 2618755
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00500.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
        500
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22889accaa-7f62-4da4-84ea-80ecfb144209%22
        spl effective date
        2025-10-27
        spl effective time
        20251027
        spl set id
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        spl version
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        substance names
        1. SODIUM THIOSULFATE
        uniis
        1. HX1032V43M
        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
          NDA212937
          payload
          all indexed label documents
          1. Appl No
            212937
            Application Docs Date
            2022-09-20 00:00:00
            Application Docs ID
            72117
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            212937
            Review Priority
            PRIORITY
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2022-09-20 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA212937
          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
          2022-09-20
          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
            212937
            Application Docs Date
            2022-09-20 00:00:00
            Application Docs ID
            72117
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          212937
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          FENNEC PHARMS INC
          openfda application present
          true
          products
          1. Active Ingredient
            SODIUM THIOSULFATE
            Appl No
            212937
            Drug Name
            PEDMARK
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            12.5GM/100ML (125MG/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. NDA212937
        brand names
        1. PEDMARK
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        3. positive_statement_also_contains_qualification_review_required
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        396
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity whe
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        generic names
        1. SODIUM THIOSULFATE
        id
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        label id
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        exact text
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        qualifier mentions
        1. context exact
          reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic sol
          kind
          age
          polarity
          not_inferred
          span
          end
          126
          end exclusive
          true
          exact text
          pediatric patients
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          889accaa-7f62-4da4-84ea-80ecfb144209
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        2. context exact
          atric patients 1 month of age and older with localized, non-metastatic solid tumors.
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          end exclusive
          true
          exact text
          metastatic solid tumors
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        3. context exact
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          kind
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          metastatic solid tumors
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            true
            exact text
            1 INDICATIONS AND USAGE PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
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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 indication
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            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 · limitation of use
            application numbers
            1. NDA212937
            brand names
            1. PEDMARK
            classification reasons
            1. negative_or_not_established_clause
            clinical review status
            pending
            content role
            limitation_of_use
            context span
            end
            545
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred. PEDMARK is indicated to reduce the r
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            id
            ind-span-0a51302bbc4d510bef48
            label id
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            positive predicate support span
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                  exact text
                  Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours.
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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
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                  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
                  not_applicable
                  Passage 3 · risk or warning
                  application numbers
                  1. NDA212937
                  brand names
                  1. PEDMARK
                  classification reasons
                  1. risk_or_warning_words_without_positive_predicate
                  clinical review status
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                  content role
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                  context span
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                  708
                  end exclusive
                  true
                  exact text
                  older with localized, non-metastatic solid tumors. Limitations of Use The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred. PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. ( 1 ) Limitations of Use:
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                        exact text
                        PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
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                        source url
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                        spl effective date
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                        Source null
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                        Source null
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                        Source null
                        disease stage
                        Source null
                        limitations
                        Source null
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                        Source null
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                        Source null
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                        Source null
                        tumor histology
                        Source null
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                        Passage 4 · positive indication candidate
                        application numbers
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                        brand names
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                        clinical review status
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                        exact text
                        latin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred. PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. ( 1 ) Limitations of Use: The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxic
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                        qualifier mentions
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                            PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
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                            source url
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                            spl effective date
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                            Source null
                            approval pathway
                            Source null
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                            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 5 · limitation of use
                            application numbers
                            1. NDA212937
                            brand names
                            1. PEDMARK
                            classification reasons
                            1. negative_or_not_established_clause
                            clinical review status
                            pending
                            content role
                            limitation_of_use
                            context span
                            end
                            1000
                            end exclusive
                            true
                            exact text
                            may have already occurred. PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. ( 1 ) Limitations of Use: The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
                            label id
                            889accaa-7f62-4da4-84ea-80ecfb144209
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            da461dee690395424956f5aa2d98176c8429fd8a9544806fa3952c866bd00418
                            start
                            482
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-4243c01e29004a4077e6
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. SODIUM THIOSULFATE
                            id
                            ind-span-f12176d156cc1bb0607c
                            label id
                            889accaa-7f62-4da4-84ea-80ecfb144209
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                source defined aliases
                                  source span
                                  end
                                  837
                                  end exclusive
                                  true
                                  exact text
                                  ( 1 ) Limitations of Use: The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours.
                                  label id
                                  889accaa-7f62-4da4-84ea-80ecfb144209
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  da461dee690395424956f5aa2d98176c8429fd8a9544806fa3952c866bd00418
                                  start
                                  682
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22889accaa-7f62-4da4-84ea-80ecfb144209%22
                                  spl effective date
                                  2025-10-27
                                  spl set id
                                  f98c7076-2a7b-4fd7-ab90-eed5e9137bae
                                  spl version
                                  7
                                  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
                                  not_applicable
                                  Passage 6 · risk or warning
                                  application numbers
                                  1. NDA212937
                                  brand names
                                  1. PEDMARK
                                  classification reasons
                                  1. risk_or_warning_words_without_positive_predicate
                                  clinical review status
                                  pending
                                  content role
                                  risk_or_warning
                                  context span
                                  end
                                  1000
                                  end exclusive
                                  true
                                  exact text
                                  ith localized, non-metastatic solid tumors. ( 1 ) Limitations of Use: The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
                                  label id
                                  889accaa-7f62-4da4-84ea-80ecfb144209
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  da461dee690395424956f5aa2d98176c8429fd8a9544806fa3952c866bd00418
                                  start
                                  638
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-1b68fb0f0d22fa04af56
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. SODIUM THIOSULFATE
                                  id
                                  ind-span-3708d39cdbdf3a1f0557
                                  label id
                                  889accaa-7f62-4da4-84ea-80ecfb144209
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                      source defined aliases
                                        source span
                                        end
                                        1000
                                        end exclusive
                                        true
                                        exact text
                                        PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
                                        label id
                                        889accaa-7f62-4da4-84ea-80ecfb144209
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        da461dee690395424956f5aa2d98176c8429fd8a9544806fa3952c866bd00418
                                        start
                                        838
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%22889accaa-7f62-4da4-84ea-80ecfb144209%22
                                        spl effective date
                                        2025-10-27
                                        spl set id
                                        f98c7076-2a7b-4fd7-ab90-eed5e9137bae
                                        spl version
                                        7
                                        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
                                        not_applicable

                                        Preserved source evidence · Not medical advice