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LABELS · 52286976-a97a-4b77-b678-f40ab5aa7133

PARSABIV

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
2026-03-08
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 PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. ( 1 ) Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations. Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations .
Full extracted label fields
application numbers
  1. NDA208325
boxed warning exact
    brand names
    1. PARSABIV
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c
    generic names
    1. ETELCALCETIDE
    id
    52286976-a97a-4b77-b678-f40ab5aa7133
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. ( 1 ) Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations. Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Amgen, Inc
      matched search terms
      1. carcinoma
      package ndcs
      1. 55513-740-01
      2. 55513-740-10
      3. 55513-740-20
      4. 55513-741-01
      5. 55513-741-10
      6. 55513-741-20
      7. 55513-742-01
      8. 55513-742-10
      9. 55513-742-20
      product ndcs
      1. 55513-740
      2. 55513-741
      3. 55513-742
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1876127
        2. 1876132
        3. 1876135
        4. 1876136
        5. 1876137
        6. 1876138
        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
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        skip
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        830
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        url
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        source url
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        spl effective date
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        spl effective time
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        substance names
        1. ETELCALCETIDE HYDROCHLORIDE
        uniis
        1. 72PT5993DU
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
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        Drugs@FDA application source records
        1. application number
          NDA208325
          payload
          all indexed label documents
          1. Appl No
            208325
            Application Docs Date
            2017-02-08 00:00:00
            Application Docs ID
            47131
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            208325
            Application Docs Date
            2018-08-21 00:00:00
            Application Docs ID
            55255
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            208325
            Application Docs Date
            2019-03-12 00:00:00
            Application Docs ID
            57962
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            208325
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2017-02-07 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            208325
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2018-08-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            208325
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2019-03-08 00:00:00
            Submission Type
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            Submissions Public Notes
          4. Appl No
            208325
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2021-02-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
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          approval interpretation
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          current indication status
          not_reconciled
          has approved submission record
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          latest approved submission date
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          latest posted label documents
          1. Appl No
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            Application Docs Date
            2019-03-12 00:00:00
            Application Docs ID
            57962
            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
          NDA
          Sponsor Name
          KAI PHARMS INC
          openfda application present
          true
          products
          1. Active Ingredient
            ETELCALCETIDE
            Appl No
            208325
            Drug Name
            PARSABIV
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            2.5MG/0.5ML (2.5MG/0.5ML)
            marketing status
            1. Prescription
          2. Active Ingredient
            ETELCALCETIDE
            Appl No
            208325
            Drug Name
            PARSABIV
            Form
            SOLUTION;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            5MG/ML (5MG/ML)
            marketing status
            1. Prescription
          3. Active Ingredient
            ETELCALCETIDE
            Appl No
            208325
            Drug Name
            PARSABIV
            Form
            SOLUTION;INTRAVENOUS
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            10MG/2ML (5MG/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. NDA208325
        brand names
        1. PARSABIV
        classification reasons
        1. explicit_positive_indication_predicate
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        clinical review status
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        1 INDICATIONS AND USAGE PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. ( 1 ) Limitations of Use: PARSAB
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            1 INDICATIONS AND USAGE PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
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            1 INDICATIONS AND USAGE PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. ( 1 ) Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for u
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                        end
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                        exact text
                        Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations .
                        label id
                        52286976-a97a-4b77-b678-f40ab5aa7133
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                        0
                        source field
                        indications_and_usage_exact
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                        https://api.fda.gov/drug/label.json?search=id%3A%2252286976-a97a-4b77-b678-f40ab5aa7133%22
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                        2026-03-08
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                        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
                        not_applicable

                        Preserved source evidence · Not medical advice