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LABELS · e6e4f66b-e398-44d3-a832-e5a809f3e861

HYCAMTIN

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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
2022-07-07
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions ( 5.1 )] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.4 , 5.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin ( 1.3 ) 1.1 Ovarian Cancer HYCAMTIN ® for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. 1.2 Small Cell Lung Cancer HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first‑line chemotherapy. 1.3 Cervical Cancer HYCAMTIN for injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.
Full extracted label fields
application numbers
  1. NDA020671
boxed warning exact
  1. WARNING: MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions ( 5.1 )] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.4 , 5.1 ).
brand names
  1. HYCAMTIN
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeee060c-a9ec-423e-a374-8484009f8524
generic names
  1. TOPOTECAN HYDROCHLORIDE
id
e6e4f66b-e398-44d3-a832-e5a809f3e861
indications and usage exact
  1. 1 INDICATIONS AND USAGE HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin ( 1.3 ) 1.1 Ovarian Cancer HYCAMTIN ® for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. 1.2 Small Cell Lung Cancer HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first‑line chemotherapy. 1.3 Cervical Cancer HYCAMTIN for injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Novartis Pharmaceuticals Corporation
    matched search terms
    1. cancer
    package ndcs
    1. 0078-0674-61
    product ndcs
    1. 0078-0674
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. INTRAVENOUS
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      1. 637550
      2. 1799416
      source batch
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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.
      last updated
      2026-09-09
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      url
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      source url
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      spl effective date
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      spl version
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      substance names
      1. TOPOTECAN HYDROCHLORIDE
      uniis
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      verification flags
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      Drugs@FDA application source records
      1. application number
        NDA020671
        payload
        all indexed label documents
        1. Appl No
          020671
          Application Docs Date
          1998-11-30 00:00:00
          Application Docs ID
          13180
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        2. Appl No
          020671
          Application Docs Date
          2006-06-15 00:00:00
          Application Docs ID
          13181
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        3. Appl No
          020671
          Application Docs Date
          2010-04-05 00:00:00
          Application Docs ID
          13182
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        4. Appl No
          020671
          Application Docs Date
          2014-03-04 00:00:00
          Application Docs ID
          13183
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        5. Appl No
          020671
          Application Docs Date
          2003-05-29 00:00:00
          Application Docs ID
          35120
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        6. Appl No
          020671
          Application Docs Date
          2010-04-05 00:00:00
          Application Docs ID
          35121
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        7. Appl No
          020671
          Application Docs Date
          2015-06-04 00:00:00
          Application Docs ID
          35122
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        8. Appl No
          020671
          Application Docs Date
          2018-09-06 00:00:00
          Application Docs ID
          55390
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          23
          Submission Type
          SUPPL
        9. Appl No
          020671
          Application Docs Date
          2019-10-15 00:00:00
          Application Docs ID
          60566
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          24
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2019-10-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2018-09-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2015-06-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2014-02-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2010-03-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2010-03-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          020671
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2006-06-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2003-05-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2003-03-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          020671
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2003-02-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          020671
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2002-03-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          020671
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2001-08-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA020671
        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
        2019-10-08
        latest label selection rule
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        latest posted label documents
        1. Appl No
          020671
          Application Docs Date
          2019-10-15 00:00:00
          Application Docs ID
          60566
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Submission Type
          SUPPL
        official application record
        Appl No
        020671
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        SANDOZ
        openfda application present
        true
        products
        1. Active Ingredient
          TOPOTECAN HYDROCHLORIDE
          Appl No
          020671
          Drug Name
          HYCAMTIN
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 4MG BASE/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. NDA020671
      brand names
      1. HYCAMTIN
      classification reasons
      1. explicit_positive_indication_predicate
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      exact text
      1 INDICATIONS AND USAGE HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B,
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      1. TOPOTECAN HYDROCHLORIDE
      id
      ind-span-d2dcf300d9c1ed4801e5
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      is a topoisomerase inhibitor indicated
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      1. context exact
        omerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as
        kind
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          1 INDICATIONS AND USAGE HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 )
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          Source null
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                              Preserved source evidence · Not medical advice