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LABELS · a11b84ff-6eb6-4bba-9c7c-6d41bdfe2d57

Photofrin

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
2026-04-28
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer ( 1.2 ) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus ( 1.3 ) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer PHOTOFRIN ® is indicated for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their healthcare provider, cannot be satisfactorily treated with Nd:YAG laser therapy. 1.2 Endobronchial Cancer PHOTOFRIN is indicated for the treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC. 1.3 High-Grade Dysplasia in Barrett’s Esophagus PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy.
Full extracted label fields
application numbers
  1. NDA020451
boxed warning exact
    brand names
    1. Photofrin
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5c4841b4-fbc0-4163-8ee1-cb28629cbfbf
    generic names
    1. PORFIMER SODIUM
    id
    a11b84ff-6eb6-4bba-9c7c-6d41bdfe2d57
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer ( 1.2 ) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus ( 1.3 ) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer PHOTOFRIN ® is indicated for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their healthcare provider, cannot be satisfactorily treated with Nd:YAG laser therapy. 1.2 Endobronchial Cancer PHOTOFRIN is indicated for the treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC. 1.3 High-Grade Dysplasia in Barrett’s Esophagus PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Pinnacle Biologics, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 76128-155-75
      product ndcs
      1. 76128-155
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Embryo-Fetal Toxicity ( 5.12 ) 12/2019
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 242166
      2. 687066
      source batch
      file
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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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      sha256
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      url
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      spl effective date
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      spl effective time
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      substance names
      1. PORFIMER SODIUM
      uniis
      1. Y3834SIK5F
      verification flags
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      1. application number
        NDA020451
        payload
        all indexed label documents
        1. Appl No
          020451
          Application Docs Date
          2003-08-14 00:00:00
          Application Docs ID
          12602
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        2. Appl No
          020451
          Application Docs Date
          2011-04-04 00:00:00
          Application Docs ID
          12603
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        3. Appl No
          020451
          Application Docs Date
          2008-09-09 00:00:00
          Application Docs ID
          34674
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        4. Appl No
          020451
          Application Docs Date
          2011-06-28 00:00:00
          Application Docs ID
          34675
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          23
          Submission Type
          SUPPL
        5. Appl No
          020451
          Application Docs Date
          2020-01-06 00:00:00
          Application Docs ID
          61516
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          29
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          020451
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2020-01-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          020451
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2011-06-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          020451
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2011-04-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          020451
          Review Priority
          UNKNOWN
          Submission Class Code ID
          2
          Submission No
          19
          Submission Status
          AP
          Submission Status Date
          2008-09-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          020451
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2005-09-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          020451
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2002-07-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          020451
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2003-08-01 00:00:00
          Submission Type
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          Submissions Public Notes
        8. Appl No
          020451
          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2001-09-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          020451
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2001-05-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          020451
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2001-06-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          020451
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2000-07-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          020451
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          1999-03-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA020451
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
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        has approved submission record
        true
        latest approved submission date
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        latest posted label documents
        1. Appl No
          020451
          Application Docs Date
          2020-01-06 00:00:00
          Application Docs ID
          61516
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          29
          Submission Type
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        official application record
        Appl No
        020451
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        PINNACLE BIOLGS
        openfda application present
        true
        products
        1. Active Ingredient
          PORFIMER SODIUM
          Appl No
          020451
          Drug Name
          PHOTOFRIN
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          75MG/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
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      clinical review status
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      context span
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      exact text
      1 INDICATIONS AND USAGE PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer ( 1.2 ) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus ( 1.3 ) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer PHOTOFRIN ® is indicated for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the op
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            1 INDICATIONS AND USAGE PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer ( 1.2 ) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus ( 1.3 ) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy
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            tially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus ( 1.3 ) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer PHOTOFRIN ® is indicated for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their healthcare provider, cannot be satisfactorily treated with Nd:YAG laser therapy. 1.2 Endobronchial Cancer PHOTOFRIN is indicated for the treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated. PH
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                  1.1 Esophageal Cancer PHOTOFRIN ® is indicated for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their healthcare provider, cannot be satisfactorily treated with Nd:YAG laser therapy.
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                  bstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their healthcare provider, cannot be satisfactorily treated with Nd:YAG laser therapy. 1.2 Endobronchial Cancer PHOTOFRIN is indicated for the treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC. 1.3 High-Grade Dysplasia in Barrett’s Esop
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                        1.2 Endobronchial Cancer PHOTOFRIN is indicated for the treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated.
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                                    Preserved source evidence · Not medical advice