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LABELS · b34597a1-251b-4c4b-9457-c3de26d5c26e

Oziltus

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
2025-12-22
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Oziltus is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Oziltus is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Oziltus is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Full extracted label fields
application numbers
  1. BLA761457
boxed warning exact
    brand names
    1. Oziltus
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f040a245-1be4-4962-a8b7-a13ee7fac707
    generic names
    1. DENOSUMAB-MOBZ
    id
    b34597a1-251b-4c4b-9457-c3de26d5c26e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Oziltus is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Oziltus is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Oziltus is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Amneal Pharmaceuticals LLC
      matched search terms
      1. myeloma
      2. tumor
      3. tumors
      4. malignancy
      package ndcs
      1. 70121-2701-1
      product ndcs
      1. 70121-2701
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2729323
        2. 2729330
        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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        spl effective date
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        1. DENOSUMAB
        uniis
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        Drugs@FDA application source records
        1. application number
          BLA761457
          payload
          all indexed label documents
          1. Appl No
            761457
            Application Docs Date
            2026-01-06 00:00:00
            Application Docs ID
            84691
            Application Docs Title
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            Application Docs Type ID
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            Submission No
            1
            Submission Type
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          all submission records
          1. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            1
            Submission Status
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            Submission Status Date
            2025-12-19 00:00:00
            Submission Type
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            Submissions Public Notes
          application number
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          approval interpretation
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          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
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            Application Docs Date
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            Application Docs ID
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            Application Docs Title
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            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
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          Sponsor Name
          AMNEAL PHARMS LLC
          openfda application present
          true
          products
          1. Active Ingredient
            DENOSUMAB-MOBZ
            Appl No
            761457
            Drug Name
            OZILTUS
            Form
            INJECTABLE;SUBCUTANEOUS
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            120MG/1.7ML (70MG/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
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        brand names
        1. Oziltus
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        clinical review status
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        true
        exact text
        1 INDICATIONS AND USAGE Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Tr
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        qualifier mentions
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            1 INDICATIONS AND USAGE Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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            Source null
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            Source null
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            Source null
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            Source null
            use intent
            supportive_care_candidate
            Passage 2 · positive indication candidate
            application numbers
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            ONS AND USAGE Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Oziltus is indicated for the preventio
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              ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of
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                ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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                rom solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Oziltus is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metas
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                    l tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Oziltus is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases fr
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                                      Preserved source evidence · Not medical advice