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LABELS · 00774850-56e9-4fb9-85e8-586967a9a5f1

Turalio

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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
2025-01-16
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATOTOXICITY TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome [see Warnings and Precautions (5.1) ] . Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) ] . TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program [see Warnings and Precautions (5.2) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome. ( 5.1 ) Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury. ( 2.2 , 5.1 ) TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program. ( 5.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. ( 1 )
Full extracted label fields
application numbers
  1. NDA211810
boxed warning exact
  1. WARNING: HEPATOTOXICITY TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome [see Warnings and Precautions (5.1) ] . Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) ] . TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program [see Warnings and Precautions (5.2) ] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome. ( 5.1 ) Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury. ( 2.2 , 5.1 ) TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program. ( 5.2 )
brand names
  1. Turalio
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16
generic names
  1. PEXIDARTINIB HYDROCHLORIDE
id
00774850-56e9-4fb9-85e8-586967a9a5f1
indications and usage exact
  1. 1 INDICATIONS AND USAGE TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Daiichi Sankyo Inc.
    matched search terms
    1. tumor
    package ndcs
    1. 65597-407-20
    2. 65597-407-28
    product ndcs
    1. 65597-407
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warning 1/2025 Warnings and Precautions ( 5.1 ) 1/2025
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    routes
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    2. 2626399
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    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.
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    url
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    spl effective date
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    spl effective time
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    substance names
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    verification flags
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    Drugs@FDA application source records
    1. application number
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      payload
      all indexed label documents
      1. Appl No
        211810
        Application Docs Date
        2019-08-02 00:00:00
        Application Docs ID
        59568
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        211810
        Application Docs Date
        2020-04-23 00:00:00
        Application Docs ID
        62655
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        3
        Submission Type
        SUPPL
      3. Appl No
        211810
        Application Docs Date
        2021-10-21 00:00:00
        Application Docs ID
        69058
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      4. Appl No
        211810
        Application Docs Date
        2022-07-15 00:00:00
        Application Docs ID
        71572
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      5. Appl No
        211810
        Application Docs Date
        2022-10-17 00:00:00
        Application Docs ID
        72391
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      6. Appl No
        211810
        Application Docs Date
        2023-11-17 00:00:00
        Application Docs ID
        76601
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        12
        Submission Type
        SUPPL
      7. Appl No
        211810
        Application Docs Date
        2025-01-03 00:00:00
        Application Docs ID
        80814
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        13
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        211810
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2025-08-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2025-01-03 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2023-11-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        211810
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2023-04-17 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2022-07-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2022-10-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2022-10-06 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2021-10-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        211810
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2020-12-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        211810
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2020-08-04 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      12. Appl No
        211810
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2020-04-17 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
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      approval interpretation
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      current indication status
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      has approved submission record
      true
      latest approved submission date
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      1. Appl No
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        Application Docs Date
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        Application Docs ID
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      Appl Public Notes
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      Sponsor Name
      DAIICHI SANKYO INC
      openfda application present
      true
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      1. Active Ingredient
        PEXIDARTINIB HYDROCHLORIDE
        Appl No
        211810
        Drug Name
        TURALIO
        Form
        CAPSULE;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        EQ 200MG BASE
        marketing status
        1. Discontinued
      2. Active Ingredient
        PEXIDARTINIB HYDROCHLORIDE
        Appl No
        211810
        Drug Name
        TURALIO
        Form
        CAPSULE;ORAL
        Product No
        002
        Reference Drug
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        Reference Standard
        1
        Strength
        EQ 125MG 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
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    1 INDICATIONS AND USAGE TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not am
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        ated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. ( 1 )
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            ated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. ( 1 )
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                  51beebf61b9dca669803a0104b34285974b13aa860983371512990d4e6749e34
                  start
                  475
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%2200774850-56e9-4fb9-85e8-586967a9a5f1%22
                  spl effective date
                  2025-01-16
                  spl set id
                  7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16
                  spl version
                  8
                  structured fields status
                  not_extracted_no_values_inferred_from_mentions
                  structured indication
                  age
                  Source null
                  approval pathway
                  Source null
                  biomarker and test
                  Source null
                  disease stage
                  Source null
                  limitations
                  Source null
                  line
                  Source null
                  prior therapy
                  Source null
                  regimen
                  Source null
                  tumor histology
                  Source null
                  use intent
                  unclear

                  Preserved source evidence · Not medical advice