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LABELS · fd28ffaf-5b17-43e7-bc91-fd623819340e

CERIANNA

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
2026-01-12
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. ( 1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). ( 1 , 5.1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
Full extracted label fields
application numbers
  1. NDA212155
boxed warning exact
    brand names
    1. CERIANNA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b2c2a2df-cf3e-4a29-a033-231ed5a94b58
    generic names
    1. FLUOROESTRADIOL F 18
    id
    fd28ffaf-5b17-43e7-bc91-fd623819340e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. ( 1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). ( 1 , 5.1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. GE Healthcare Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 72874-001-01
      product ndcs
      1. 72874-001
      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-00800.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
          800
          total
          830
          sha256
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          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=800&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22fd28ffaf-5b17-43e7-bc91-fd623819340e%22
          spl effective date
          2026-01-12
          spl effective time
          20260112
          spl set id
          b2c2a2df-cf3e-4a29-a033-231ed5a94b58
          spl version
          27
          substance names
          1. FLUOROESTRADIOL F-18
          uniis
          1. T32277KB09
          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
            NDA212155
            payload
            all indexed label documents
            1. Appl No
              212155
              Application Docs Date
              2020-05-22 00:00:00
              Application Docs ID
              63258
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              212155
              Application Docs Date
              2024-05-07 00:00:00
              Application Docs ID
              78412
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              21
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              212155
              Review Priority
              STANDARD
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2020-05-20 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              212155
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              14
              Submission Status
              AP
              Submission Status Date
              2022-04-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              212155
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              21
              Submission Status
              AP
              Submission Status Date
              2024-05-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA212155
            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
            2024-05-06
            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
              212155
              Application Docs Date
              2024-05-07 00:00:00
              Application Docs ID
              78412
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              21
              Submission Type
              SUPPL
            official application record
            Appl No
            212155
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            GE HEALTHCARE
            openfda application present
            true
            products
            1. Active Ingredient
              FLUOROESTRADIOL F-18
              Appl No
              212155
              Drug Name
              CERIANNA
              Form
              SOLUTION;INTRAVENOUS
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              50ML (4-100mCi/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. NDA212155
          brand names
          1. CERIANNA
          classification reasons
          1. explicit_positive_indication_predicate
          2. diagnostic_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          442
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in pa
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          generic names
          1. FLUOROESTRADIOL F 18
          id
          ind-span-a91896c2a62b2346c1cb
          label id
          fd28ffaf-5b17-43e7-bc91-fd623819340e
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          true
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          qualifier mentions
          1. context exact
            sions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            241
            end exclusive
            true
            exact text
            metastatic breast cancer
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          2. context exact
            )-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
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            end exclusive
            true
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            recurrent or metastatic breast cancer
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          regulatory links
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              exact text
              1 INDICATIONS AND USAGE CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
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              source url
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              spl effective date
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              spl set id
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              spl version
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              structured fields status
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              structured indication
              age
              Source null
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              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
              Passage 2 · positive indication candidate
              application numbers
              1. NDA212155
              brand names
              1. CERIANNA
              classification reasons
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              2. diagnostic_use_words
              clinical review status
              pending
              content role
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              692
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              true
              exact text
              ed for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. ( 1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human ep
              label id
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              not_reconciled
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              extraction review status
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              generic names
              1. FLUOROESTRADIOL F 18
              id
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              exact text
              is a radioactive diagnostic agent indicated
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              qualifier mentions
              1. context exact
                sions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
                kind
                biomarker
                polarity
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                span
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                491
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                true
                exact text
                metastatic breast cancer
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              2. context exact
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                true
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                recurrent or metastatic breast cancer
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              regulatory links
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                source defined aliases
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                  true
                  exact text
                  CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
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                  source url
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                  spl effective date
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                  spl set id
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                  Source null
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                  limitations
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                  regimen
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                  tumor histology
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                  application numbers
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                  ed for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. ( 1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). ( 1 , 5.1 ) Limitations of Use Tissue biopsy should be
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                        ( 1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology.
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                        source url
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                        exact text
                        ct to biopsy in patients with recurrent or metastatic breast cancer. ( 1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). ( 1 , 5.1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as hu
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                          eceptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
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                          HER2) and the progesterone receptor (PR)
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                            CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
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                            spl effective date
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                            spl set id
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                            Source null
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                            Source null
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                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
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                            Source null
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                            of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR). ( 1 , 5.1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
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                                  ( 1 , 5.1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology.
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                                  regimen
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                                  tumor histology
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                                  h factor receptor 2 (HER2) and the progesterone receptor (PR). ( 1 , 5.1 ) Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
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                                      CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
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                                      spl set id
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                                      limitations
                                      Source null
                                      line
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                                      prior therapy
                                      Source null
                                      regimen
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                                      tumor histology
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                                      use intent
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                                      Preserved source evidence · Not medical advice