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LABELS · 4cc23694-63af-f9f1-e063-6394a90a4ce0

Cytalux

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
2026-04-01
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 CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )
Full extracted label fields
application numbers
  1. NDA214907
boxed warning exact
    brand names
    1. Cytalux
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d21952b9-7c4e-3a56-e053-2a95a90a0ab0
    generic names
    1. PAFOLACIANINE INJECTION
    id
    4cc23694-63af-f9f1-e063-6394a90a4ce0
    indications and usage exact
    1. 1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. On Target Laboratories, Inc.
      matched search terms
      1. cancer
      2. malignant
      package ndcs
      1. 81052-138-01
      2. 81052-138-10
      product ndcs
      1. 81052-138
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. RECENT MAJOR CHANGES Dosage and Administration, 7/2025 Preparation and Storage Instructions ( 2.3 )
      record type
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      routes
      1. INTRAVENOUS
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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
        results
        limit
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        300
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        830
        sha256
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        url
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        source url
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        1. application number
          NDA214907
          payload
          all indexed label documents
          1. Appl No
            214907
            Application Docs Date
            2021-11-30 00:00:00
            Application Docs ID
            69426
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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            Submission Type
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            Application Docs Date
            2022-12-19 00:00:00
            Application Docs ID
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            Application Docs Title
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            Application Docs Type ID
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            Submission No
            2
            Submission Type
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          all submission records
          1. Appl No
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            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2021-11-29 00:00:00
            Submission Type
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            Submissions Public Notes
          2. Appl No
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            Review Priority
            PRIORITY
            Submission Class Code ID
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            Submission No
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            Submission Status Date
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            Submissions Public Notes
          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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            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
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          Sponsor Name
          ON TARGET LABS
          openfda application present
          true
          products
          1. Active Ingredient
            PAFOLACIANINE SODIUM
            Appl No
            214907
            Drug Name
            CYTALUX
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)
            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 · unclassified context
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        1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions i
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              Passage 2 · positive indication candidate
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              1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identificati
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                  INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer.
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                  1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesion
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                      intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )
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                          with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )
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                          1. PAFOLACIANINE INJECTION
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                          true
                          exact text
                          is an optical imaging agent indicated
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                          4cc23694-63af-f9f1-e063-6394a90a4ce0
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                          start
                          271
                          qualifier mentions
                          1. context exact
                            Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
                            kind
                            age
                            polarity
                            not_inferred
                            span
                            end
                            481
                            end exclusive
                            true
                            exact text
                            adult patients
                            label id
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                          regulatory links
                            schema version
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                              525
                              end exclusive
                              true
                              exact text
                              Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
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                              4cc23694-63af-f9f1-e063-6394a90a4ce0
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                              283bc0244e81c872d5bf1d08a6e7654d9a40b1c09e5a7e387141075db4a5718e
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                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%224cc23694-63af-f9f1-e063-6394a90a4ce0%22
                              spl effective date
                              2026-04-01
                              spl set id
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                              spl version
                              10
                              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 6 · unclassified context
                              application numbers
                              1. NDA214907
                              brand names
                              1. Cytalux
                              classification reasons
                              1. no_unambiguous_positive_indication_predicate
                              clinical review status
                              pending
                              content role
                              unclassified_context
                              context span
                              end
                              531
                              end exclusive
                              true
                              exact text
                              intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )
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                              4cc23694-63af-f9f1-e063-6394a90a4ce0
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                              326
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-61bf7afd843bc589eb02
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. PAFOLACIANINE INJECTION
                              id
                              ind-span-1142a398f5c1e4e3b46e
                              label id
                              4cc23694-63af-f9f1-e063-6394a90a4ce0
                              positive predicate support span
                              Source null
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
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                                  source defined aliases
                                    source span
                                    end
                                    531
                                    end exclusive
                                    true
                                    exact text
                                    ( 1 )
                                    label id
                                    4cc23694-63af-f9f1-e063-6394a90a4ce0
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    283bc0244e81c872d5bf1d08a6e7654d9a40b1c09e5a7e387141075db4a5718e
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                                    526
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%224cc23694-63af-f9f1-e063-6394a90a4ce0%22
                                    spl effective date
                                    2026-04-01
                                    spl set id
                                    d21952b9-7c4e-3a56-e053-2a95a90a0ab0
                                    spl version
                                    10
                                    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