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LABELS · ac5e7507-8e66-4da5-abd9-75ae80369b9f

FeraBright

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
2025-10-14
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol. Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration [see Warnings and Precautions ( 5.1 )] . WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol. Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. FERABRIGHT is an iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
Full extracted label fields
application numbers
  1. NDA219868
boxed warning exact
  1. WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol. Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration [see Warnings and Precautions ( 5.1 )] . WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol. Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration. ( 5.1 )
brand names
  1. FeraBright
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac666008-a14f-43b4-9d06-ec70f45a4234
generic names
  1. FERUMOXYTOL
id
ac5e7507-8e66-4da5-abd9-75ae80369b9f
indications and usage exact
  1. 1 INDICATIONS AND USAGE FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. FERABRIGHT is an iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Azurity Pharmaceuticals, Inc.
    matched search terms
    1. neoplasms
    2. malignant
    package ndcs
    1. 24338-310-10
    2. 24338-510-17
    product ndcs
    1. 24338-310
    2. 24338-510
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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        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.
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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
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        uniis
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        Drugs@FDA application source records
        1. application number
          NDA219868
          payload
          all indexed label documents
          1. Appl No
            219868
            Application Docs Date
            2025-10-21 00:00:00
            Application Docs ID
            83838
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
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            Submission Type
            ORIG
          all submission records
          1. Appl No
            219868
            Review Priority
            STANDARD
            Submission Class Code ID
            22
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-10-16 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA219868
          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
          2025-10-16
          latest label selection rule
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          latest posted label documents
          1. Appl No
            219868
            Application Docs Date
            2025-10-21 00:00:00
            Application Docs ID
            83838
            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
          AZURITY
          openfda application present
          true
          products
          1. Active Ingredient
            FERUMOXYTOL
            Appl No
            219868
            Drug Name
            FERABRIGHT
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 300MG IRON/10ML (EQ 30MG IRON/ML)
            marketing status
            1. Prescription
          2. Active Ingredient
            FERUMOXYTOL
            Appl No
            219868
            Drug Name
            FERABRIGHT
            Form
            SOLUTION;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 510MG IRON/17ML (EQ 30MG IRON/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. FeraBright
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        exact text
        1 INDICATIONS AND USAGE FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. FERABRIGHT is an iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a d
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        qualifier mentions
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            exact text
            1 INDICATIONS AND USAGE FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
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            biomarker and test
            Source null
            disease stage
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            limitations
            Source null
            line
            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
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            Passage 2 · positive indication candidate
            application numbers
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            exact text
            FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. FERABRIGHT is an iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
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            exact text
            is an iron-based contrast agent indicated
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                exact text
                FERABRIGHT is an iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
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                biomarker and test
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                disease stage
                Source null
                limitations
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                line
                Source null
                prior therapy
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                regimen
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                tumor histology
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                use intent
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                Preserved source evidence · Not medical advice