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LABELS · 5d893369-497c-46ee-9b64-ee737fab4225

Venclexta

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
2026-05-20
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.2 Acute Myeloid Leukemia VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Full extracted label fields
application numbers
  1. NDA208573
boxed warning exact
    brand names
    1. Venclexta
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b118a40d-6b56-cee3-10f6-ded821a97018
    generic names
    1. VENETOCLAX
    id
    5d893369-497c-46ee-9b64-ee737fab4225
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.2 Acute Myeloid Leukemia VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. AbbVie Inc.
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 0074-0579-28
      2. 0074-0576-22
      3. 0074-0576-11
      4. 0074-0576-34
      5. 0074-0576-30
      6. 0074-0561-14
      7. 0074-0561-11
      8. 0074-0566-07
      9. 0074-0566-11
      product ndcs
      1. 0074-0561
      2. 0074-0579
      3. 0074-0576
      4. 0074-0566
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.2 , 2.5 ) 02/2026 Dosage and Administration ( 2.8 ) 05/2026 Warnings and Precautions ( 5.2 , 5.3 ) 02/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1747561
      2. 1747567
      3. 1747572
      4. 1747574
      5. 1747575
      6. 1747577
      7. 1747579
      8. 1747580
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00300.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
      300
      total
      830
      sha256
      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
      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=300&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%225d893369-497c-46ee-9b64-ee737fab4225%22
      spl effective date
      2026-05-20
      spl effective time
      20260520
      spl set id
      b118a40d-6b56-cee3-10f6-ded821a97018
      spl version
      283
      substance names
      1. VENETOCLAX
      uniis
      1. N54AIC43PW
      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
        NDA208573
        payload
        all indexed label documents
        1. Appl No
          208573
          Application Docs Date
          2016-04-11 00:00:00
          Application Docs ID
          19998
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          208573
          Application Docs Date
          2017-12-26 00:00:00
          Application Docs ID
          50852
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          208573
          Application Docs Date
          2018-06-08 00:00:00
          Application Docs ID
          54479
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          208573
          Application Docs Date
          2018-06-08 00:00:00
          Application Docs ID
          54480
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        5. Appl No
          208573
          Application Docs Date
          2020-07-14 00:00:00
          Application Docs ID
          55427
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        6. Appl No
          208573
          Application Docs Date
          2020-07-14 00:00:00
          Application Docs ID
          55428
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        7. Appl No
          208573
          Application Docs Date
          2018-11-21 00:00:00
          Application Docs ID
          56530
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        8. Appl No
          208573
          Application Docs Date
          2019-05-15 00:00:00
          Application Docs ID
          58734
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        9. Appl No
          208573
          Application Docs Date
          2019-07-29 00:00:00
          Application Docs ID
          59485
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        10. Appl No
          208573
          Application Docs Date
          2019-07-29 00:00:00
          Application Docs ID
          59486
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        11. Appl No
          208573
          Application Docs Date
          2019-07-29 00:00:00
          Application Docs ID
          59487
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        12. Appl No
          208573
          Application Docs Date
          2020-06-02 00:00:00
          Application Docs ID
          63395
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2026-05-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2026-02-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2022-06-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2021-10-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2021-10-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2020-11-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          208573
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2020-10-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          208573
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2020-10-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2020-05-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2020-06-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2019-07-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          208573
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2019-07-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA208573
        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
        2026-05-20
        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
          208573
          Application Docs Date
          2026-05-21 00:00:00
          Application Docs ID
          86002
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        official application record
        Appl No
        208573
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ABBVIE
        openfda application present
        true
        products
        1. Active Ingredient
          VENETOCLAX
          Appl No
          208573
          Drug Name
          VENCLEXTA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          10MG
          marketing status
          1. Prescription
        2. Active Ingredient
          VENETOCLAX
          Appl No
          208573
          Drug Name
          VENCLEXTA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          marketing status
          1. Prescription
        3. Active Ingredient
          VENETOCLAX
          Appl No
          208573
          Drug Name
          VENCLEXTA
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          100MG
          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. NDA208573
      brand names
      1. Venclexta
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      378
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities
      label id
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      offset unit
      unicode_code_points
      source array index
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      source field
      indications_and_usage_exact
      source text sha256
      7c2dde222cd015dd772c76b934db74374738be1bc6a63d6115086d9426964a2f
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-e58a1f4a36d62c81e18c
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. VENETOCLAX
      id
      ind-span-d2e6427003bfcbbd846b
      label id
      5d893369-497c-46ee-9b64-ee737fab4225
      positive predicate support span
      end
      64
      end exclusive
      true
      exact text
      is a BCL-2 inhibitor indicated
      label id
      5d893369-497c-46ee-9b64-ee737fab4225
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
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      start
      34
      qualifier mentions
      1. context exact
        CLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocyti
        kind
        age
        polarity
        not_inferred
        span
        end
        101
        end exclusive
        true
        exact text
        adult patients
        label id
        5d893369-497c-46ee-9b64-ee737fab4225
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        7c2dde222cd015dd772c76b934db74374738be1bc6a63d6115086d9426964a2f
        start
        87
      regulatory links
        schema version
        0.1.0
        source batch sha256
        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
        source defined aliases
          source span
          end
          178
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
          label id
          5d893369-497c-46ee-9b64-ee737fab4225
          offset unit
          unicode_code_points
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          source field
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          source text sha256
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225d893369-497c-46ee-9b64-ee737fab4225%22
          spl effective date
          2026-05-20
          spl set id
          b118a40d-6b56-cee3-10f6-ded821a97018
          spl version
          283
          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
          tumor_directed_candidate
          Passage 2 · unclassified context
          application numbers
          1. NDA208573
          brand names
          1. Venclexta
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          386
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that pr
          label id
          5d893369-497c-46ee-9b64-ee737fab4225
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          7c2dde222cd015dd772c76b934db74374738be1bc6a63d6115086d9426964a2f
          start
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          current approval status
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          duplicate text group
          dup-b216fc4bc8e6fb821d95
          extraction review status
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          generic names
          1. VENETOCLAX
          id
          ind-span-b26b6818c1c38b104485
          label id
          5d893369-497c-46ee-9b64-ee737fab4225
          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
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              source batch sha256
              bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
              source defined aliases
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                186
                end exclusive
                true
                exact text
                ( 1.1 )
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                source text sha256
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                start
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                source url
                https://api.fda.gov/drug/label.json?search=id%3A%225d893369-497c-46ee-9b64-ee737fab4225%22
                spl effective date
                2026-05-20
                spl set id
                b118a40d-6b56-cee3-10f6-ded821a97018
                spl version
                283
                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
                Passage 3 · positive indication candidate
                application numbers
                1. NDA208573
                brand names
                1. Venclexta
                classification reasons
                1. inherited_predicate_from_same_label_section_requires_review
                2. tumor_or_malignant_hematology_words_in_positive_statement
                clinical review status
                pending
                content role
                positive_indication_candidate
                context span
                end
                633
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (S
                label id
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                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
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                start
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                current approval status
                not_reconciled
                duplicate text group
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                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. VENETOCLAX
                id
                ind-span-c9af93e033f4a9892f25
                label id
                5d893369-497c-46ee-9b64-ee737fab4225
                positive predicate support span
                end
                64
                end exclusive
                true
                exact text
                is a BCL-2 inhibitor indicated
                label id
                5d893369-497c-46ee-9b64-ee737fab4225
                offset unit
                unicode_code_points
                source array index
                0
                source field
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                source text sha256
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                start
                34
                qualifier mentions
                1. context exact
                  reatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude
                  kind
                  age
                  polarity
                  not_inferred
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                                  Preserved source evidence · Not medical advice