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LABELS · 510bc71b-20e4-428a-8fc2-29c9fc20f2f3

Pralatrexate

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
2022-11-15
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 Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
Full extracted label fields
application numbers
  1. NDA022468
boxed warning exact
    brand names
    1. Pralatrexate
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5daa583-4965-4564-ad87-41ffe6c08a11
    generic names
    1. PRALATREXATE
    id
    510bc71b-20e4-428a-8fc2-29c9fc20f2f3
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Fresenius Kabi USA, LLC
      matched search terms
      1. lymphoma
      package ndcs
      1. 65219-550-01
      2. 65219-552-02
      product ndcs
      1. 65219-550
      2. 65219-552
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1796419
        2. 1796424
        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
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22510bc71b-20e4-428a-8fc2-29c9fc20f2f3%22
        spl effective date
        2022-11-15
        spl effective time
        20221115
        spl set id
        a5daa583-4965-4564-ad87-41ffe6c08a11
        spl version
        1
        substance names
        1. PRALATREXATE
        uniis
        1. A8Q8I19Q20
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          NDA022468
          payload
          all indexed label documents
          1. Appl No
            022468
            Application Docs Date
            2009-09-25 00:00:00
            Application Docs ID
            17617
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            022468
            Application Docs Date
            2011-01-10 00:00:00
            Application Docs ID
            17618
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          3. Appl No
            022468
            Application Docs Date
            2011-01-10 00:00:00
            Application Docs ID
            17619
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          4. Appl No
            022468
            Application Docs Date
            2012-06-06 00:00:00
            Application Docs ID
            17620
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          5. Appl No
            022468
            Application Docs Date
            2016-05-17 00:00:00
            Application Docs ID
            17621
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          6. Appl No
            022468
            Application Docs Date
            2010-04-28 00:00:00
            Application Docs ID
            38743
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          7. Appl No
            022468
            Application Docs Date
            2011-01-10 00:00:00
            Application Docs ID
            38744
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          8. Appl No
            022468
            Application Docs Date
            2012-02-17 00:00:00
            Application Docs ID
            38745
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          9. Appl No
            022468
            Application Docs Date
            2012-06-06 00:00:00
            Application Docs ID
            38746
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          10. Appl No
            022468
            Application Docs Date
            2020-05-19 00:00:00
            Application Docs ID
            63137
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          11. Appl No
            022468
            Application Docs Date
            2020-10-23 00:00:00
            Application Docs ID
            65005
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            022468
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2012-05-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            022468
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2016-05-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            022468
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2020-05-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            022468
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2020-10-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            022468
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2012-05-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            022468
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2012-02-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            022468
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2011-01-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            022468
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2011-01-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            022468
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2011-01-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            022468
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2010-04-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            022468
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2009-09-24 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA022468
          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
          2020-10-20
          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
            022468
            Application Docs Date
            2020-10-23 00:00:00
            Application Docs ID
            65005
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ACROTECH BIOPHARMA
          openfda application present
          true
          products
          1. Active Ingredient
            PRALATREXATE
            Appl No
            022468
            Drug Name
            FOLOTYN
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            20MG/ML (20MG/ML)
            marketing status
            1. Prescription
          2. Active Ingredient
            PRALATREXATE
            Appl No
            022468
            Drug Name
            FOLOTYN
            Form
            SOLUTION;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            40MG/2ML (20MG/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 · positive indication candidate
        application numbers
        1. NDA022468
        brand names
        1. Pralatrexate
        classification reasons
        1. explicit_positive_indication_predicate
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        clinical review status
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        content role
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        context span
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and de
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        duplicate text group
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        generic names
        1. PRALATREXATE
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        is indicated
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        1. context exact
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          relapsed or refractory peripheral T-cell ly
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            1 INDICATIONS AND USAGE Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
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            1 INDICATIONS AND USAGE Pralatrexate injection is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pralatrexate injection is a dihydrofolate reductase inhibito
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                  This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )] .
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                  atment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under
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                        sed on overall response rate [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit i
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                                              Preserved source evidence · Not medical advice