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LABELS · fd1c99c8-df20-4278-b963-603bb0c10715

COSELA

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
2024-02-24
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. ( 1 )
Full extracted label fields
application numbers
  1. NDA214200
boxed warning exact
    brand names
    1. COSELA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b06922c-498d-4871-a037-84a44e6a6b6c
    generic names
    1. TRILACICLIB
    id
    fd1c99c8-df20-4278-b963-603bb0c10715
    indications and usage exact
    1. 1 INDICATIONS AND USAGE COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. G1 Therapeutics, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 73462-101-01
      product ndcs
      1. 73462-101
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.2 ) 8/2023
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2479705
      2. 2479710
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00800.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
      800
      total
      830
      sha256
      8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7
      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=800&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22fd1c99c8-df20-4278-b963-603bb0c10715%22
      spl effective date
      2024-02-24
      spl effective time
      20240224
      spl set id
      4b06922c-498d-4871-a037-84a44e6a6b6c
      spl version
      5
      substance names
      1. TRILACICLIB DIHYDROCHLORIDE
      uniis
      1. 4BX07W725T
      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
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        NDA214200
        payload
        all indexed label documents
        1. Appl No
          214200
          Application Docs Date
          2021-02-16 00:00:00
          Application Docs ID
          66228
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          214200
          Application Docs Date
          2023-04-10 00:00:00
          Application Docs ID
          73967
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          214200
          Application Docs Date
          2023-08-04 00:00:00
          Application Docs ID
          74999
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        4. Appl No
          214200
          Application Docs Date
          2025-08-27 00:00:00
          Application Docs ID
          83213
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          214200
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2021-02-12 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          214200
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2023-04-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          214200
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2023-08-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          214200
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2025-08-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA214200
        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
        2025-08-25
        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
          214200
          Application Docs Date
          2025-08-27 00:00:00
          Application Docs ID
          83213
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        official application record
        Appl No
        214200
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        PHARMACOSMOS
        openfda application present
        true
        products
        1. Active Ingredient
          TRILACICLIB DIHYDROCHLORIDE
          Appl No
          214200
          Drug Name
          COSELA
          Form
          POWDER;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 300MG 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. NDA214200
      brand names
      1. COSELA
      classification reasons
      1. explicit_positive_indication_predicate
      2. supportive_or_complication_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      481
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topot
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      source text sha256
      8ecaa126b65b8343f6c7d0fa8768c7fcfdd0f4d3213540a0fa28d7391d448702
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      current approval status
      not_reconciled
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      extraction review status
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      generic names
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      true
      exact text
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      source text sha256
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      start
      31
      qualifier mentions
      1. context exact
        e the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing
        kind
        age
        polarity
        not_inferred
        span
        end
        128
        end exclusive
        true
        exact text
        adult patients
        label id
        fd1c99c8-df20-4278-b963-603bb0c10715
        offset unit
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        source text sha256
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      regulatory links
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        source defined aliases
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          true
          exact text
          1 INDICATIONS AND USAGE COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).
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          source text sha256
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          source url
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          spl effective date
          2024-02-24
          spl set id
          4b06922c-498d-4871-a037-84a44e6a6b6c
          spl version
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          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
          supportive_care_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA214200
          brand names
          1. COSELA
          classification reasons
          1. explicit_positive_indication_predicate
          2. supportive_or_complication_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          554
          end exclusive
          true
          exact text
          apy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. ( 1 )
          label id
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          source text sha256
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          current approval status
          not_reconciled
          duplicate text group
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          extraction review status
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          generic names
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          id
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          label id
          fd1c99c8-df20-4278-b963-603bb0c10715
          positive predicate support span
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          end exclusive
          true
          exact text
          is a kinase inhibitor indicated
          label id
          fd1c99c8-df20-4278-b963-603bb0c10715
          offset unit
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          source array index
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          source field
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          source text sha256
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          qualifier mentions
          1. context exact
            e the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing
            kind
            age
            polarity
            not_inferred
            span
            end
            405
            end exclusive
            true
            exact text
            adult patients
            label id
            fd1c99c8-df20-4278-b963-603bb0c10715
            offset unit
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            source text sha256
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            source defined aliases
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              end exclusive
              true
              exact text
              COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
              label id
              fd1c99c8-df20-4278-b963-603bb0c10715
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              source text sha256
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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
              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
              supportive_care_candidate
              Passage 3 · unclassified context
              application numbers
              1. NDA214200
              brand names
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              classification reasons
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              clinical review status
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              content role
              unclassified_context
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              554
              end exclusive
              true
              exact text
              chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. ( 1 )
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              current approval status
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              id
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              label id
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              positive predicate support span
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              qualifier mentions
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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
                    unclear

                    Preserved source evidence · Not medical advice