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LABELS · 58257b74-15bb-d5d5-e063-6394a90accc7

Lysodren

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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
2026-03-03
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION See full prescribing information for complete boxed warning. Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs ( 2.3 , 5.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). ( 1 )
Full extracted label fields
application numbers
  1. NDA016885
boxed warning exact
  1. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION See full prescribing information for complete boxed warning. Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs ( 2.3 , 5.1 ).
brand names
  1. Lysodren
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4046a224-8832-daa2-e063-6294a90a11d7
generic names
  1. MITOTANE
id
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indications and usage exact
  1. 1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). ( 1 )
indications and usage tables exact
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    1. ESTEVE PHARMACEUTICALS, S.A.
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    1. carcinoma
    package ndcs
    1. 68118-080-60
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    1. 68118-080
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    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. BOXED WARNING 01/2024 INDICATIONS AND USAGE ( 1 ) 01/2024 DOSAGE AND ADMINISTRATION ( 2 ) 01/2024 CONTRAINDICATIONS ( 4 ) 01/2024 WARNINGS AND PRECAUTIONS ( 5 ) 01/2024
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    1. application number
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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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        Submission No
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        Application Docs ID
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        Application Docs Title
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        Application Docs Type ID
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        Submission No
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      3. Appl No
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        Application Docs Date
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        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
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      4. Appl No
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        Application Docs ID
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        Submission No
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      5. Appl No
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        Application Docs Date
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        Submission No
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      6. Appl No
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        Application Docs Date
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        Submission No
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      7. Appl No
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        Application Docs Date
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        Submission No
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      1. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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      2. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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      3. Appl No
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        Review Priority
        Submission Class Code ID
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        Submission No
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      4. Appl No
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        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
        3
        Submission Status
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        Submission Status Date
        1978-04-24 00:00:00
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      5. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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      6. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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        Submissions Public Notes
      7. Appl No
        016885
        Review Priority
        PRIORITY
        Submission Class Code ID
        4
        Submission No
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        Submission Status
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        Submission Status Date
        1985-08-06 00:00:00
        Submission Type
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        Submissions Public Notes
      8. Appl No
        016885
        Review Priority
        Submission Class Code ID
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        Submission No
        11
        Submission Status
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        Submission Status Date
        1985-09-20 00:00:00
        Submission Type
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        Submissions Public Notes
      9. Appl No
        016885
        Review Priority
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        Submission Class Code ID
        4
        Submission No
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        Submission Status
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        Submission Type
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        Submissions Public Notes
      10. Appl No
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        Review Priority
        Submission Class Code ID
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        Submission No
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      11. Appl No
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        Review Priority
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        Submission Class Code ID
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        Submission No
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      12. Appl No
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        Review Priority
        Submission Class Code ID
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        Submission No
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        Submission Status
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        Submission Status Date
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        Submissions Public Notes
      application number
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      products
      1. Active Ingredient
        MITOTANE
        Appl No
        016885
        Drug Name
        LYSODREN
        Form
        TABLET;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        500MG
        marketing status
        1. Prescription

    Source passages and status connections

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    1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). ( 1 )
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          1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).
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          1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). ( 1 )
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                LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).
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                      Preserved source evidence · Not medical advice