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LABELS · 558f7e93-a905-767a-e063-6294a90a1527

PYLARIFY TRUVU

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
2026-07-01
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 PYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PYLARIFY TRUVU is a radioactive diagnostic drug indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level ( 1 )
Full extracted label fields
application numbers
  1. NDA220089
boxed warning exact
    brand names
    1. PYLARIFY TRUVU
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=121c1cb8-6f60-4644-a775-b81c6f21d812
    generic names
    1. PIFLUFOLASTAT F-18
    id
    558f7e93-a905-767a-e063-6294a90a1527
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PYLARIFY TRUVU is a radioactive diagnostic drug indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Aphelion LLC
      matched search terms
      1. cancer
      package ndcs
      1. 85347-001-01
      product ndcs
      1. 85347-001
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
          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%22558f7e93-a905-767a-e063-6294a90a1527%22
          spl effective date
          2026-07-01
          spl effective time
          20260701
          spl set id
          121c1cb8-6f60-4644-a775-b81c6f21d812
          spl version
          5
          substance names
          1. PIFLUFOLASTAT F-18
          uniis
          1. 3934EF02T7
          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
          Drugs@FDA application source records
          1. application number
            NDA220089
            payload
            all indexed label documents
            1. Appl No
              220089
              Application Docs Date
              2026-03-12 00:00:00
              Application Docs ID
              85363
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            all submission records
            1. Appl No
              220089
              Review Priority
              STANDARD
              Submission Class Code ID
              15
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2026-03-06 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            application number
            NDA220089
            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
            2026-03-06
            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
              220089
              Application Docs Date
              2026-03-12 00:00:00
              Application Docs ID
              85363
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            official application record
            Appl No
            220089
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            APHELION
            openfda application present
            true
            products
            1. Active Ingredient
              PIFLUFOLASTAT F-18
              Appl No
              220089
              Drug Name
              PYLARIFY TRUVU
              Form
              SOLUTION;INTRAVENOUS
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              1mCi/mL-120mCi/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. NDA220089
          brand names
          1. PYLARIFY TRUVU
          classification reasons
          1. explicit_positive_indication_predicate
          2. diagnostic_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          703
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE PYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PYLARIFY TRUVU is a radioactive diagnostic drug indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level ( 1 )
          label id
          558f7e93-a905-767a-e063-6294a90a1527
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a13efcb494ae66ccc8ebbc2d87023bbd201d8622c95f8a4b8234e63cefca58ea
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-5c6b8d4fbc05e655934e
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. PIFLUFOLASTAT F-18
          id
          ind-span-3a035a985ca829e7ad84
          label id
          558f7e93-a905-767a-e063-6294a90a1527
          positive predicate support span
          end
          51
          end exclusive
          true
          exact text
          is indicated
          label id
          558f7e93-a905-767a-e063-6294a90a1527
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a13efcb494ae66ccc8ebbc2d87023bbd201d8622c95f8a4b8234e63cefca58ea
          start
          39
          qualifier mentions
          1. context exact
            ion tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for ini
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            174
            end exclusive
            true
            exact text
            PSMA) positive lesions in men with prostate
            label id
            558f7e93-a905-767a-e063-6294a90a1527
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a13efcb494ae66ccc8ebbc2d87023bbd201d8622c95f8a4b8234e63cefca58ea
            start
            130
          2. context exact
            ositive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevate
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            240
            end exclusive
            true
            exact text
            metastasis who are candidates for initial d
            label id
            558f7e93-a905-767a-e063-6294a90a1527
            offset unit
            unicode_code_points
            source array index
            0
            source field
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            source text sha256
            a13efcb494ae66ccc8ebbc2d87023bbd201d8622c95f8a4b8234e63cefca58ea
            start
            197
          3. context exact
            ion tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for ini
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            526
            end exclusive
            true
            exact text
            PSMA) positive lesions in men with prostate
            label id
            558f7e93-a905-767a-e063-6294a90a1527
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a13efcb494ae66ccc8ebbc2d87023bbd201d8622c95f8a4b8234e63cefca58ea
            start
            482
          4. context exact
            ositive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevate
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            592
            end exclusive
            true
            exact text
            metastasis who are candidates for initial d
            label id
            558f7e93-a905-767a-e063-6294a90a1527
            offset unit
            unicode_code_points
            source array index
            0
            source field
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            source text sha256
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            start
            549
          regulatory links
            schema version
            0.1.0
            source batch sha256
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            source defined aliases
              source span
              end
              703
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE PYLARIFY TRUVU is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PYLARIFY TRUVU is a radioactive diagnostic drug indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level ( 1 )
              label id
              558f7e93-a905-767a-e063-6294a90a1527
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a13efcb494ae66ccc8ebbc2d87023bbd201d8622c95f8a4b8234e63cefca58ea
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22558f7e93-a905-767a-e063-6294a90a1527%22
              spl effective date
              2026-07-01
              spl set id
              121c1cb8-6f60-4644-a775-b81c6f21d812
              spl version
              5
              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
              diagnostic_candidate

              Preserved source evidence · Not medical advice