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LABELS · 43f5835c-f395-47a4-aae6-1e81b5f9bb85

EVOMELA

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
2023-06-09
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters. [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions. [see Warnings and Precautions ( 5.4 )] Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela should be considered potentially leukemogenic in humans. [see Warnings and Precautions ( 5.5 )] WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, AND LEUKEMOGENICITY See full prescribing information for complete boxed warning. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters. ( 5.1 ) Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions. ( 5.4 ) Melphalan produces chromosomal aberrations in vitro and in vivo . Evomela should be considered potentially leukemogenic in humans. ( 5.5 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. ( 1.1 ) 1.1 Multiple Myeloma-Conditioning Treatment Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
Full extracted label fields
application numbers
  1. NDA207155
boxed warning exact
  1. WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters. [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions. [see Warnings and Precautions ( 5.4 )] Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela should be considered potentially leukemogenic in humans. [see Warnings and Precautions ( 5.5 )] WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, AND LEUKEMOGENICITY See full prescribing information for complete boxed warning. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters. ( 5.1 ) Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions. ( 5.4 ) Melphalan produces chromosomal aberrations in vitro and in vivo . Evomela should be considered potentially leukemogenic in humans. ( 5.5 )
brand names
  1. EVOMELA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=69f55869-dc11-408e-8fc7-47634269a52c
generic names
  1. MELPHALAN
id
43f5835c-f395-47a4-aae6-1e81b5f9bb85
indications and usage exact
  1. 1 INDICATIONS AND USAGE Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. ( 1.1 ) 1.1 Multiple Myeloma-Conditioning Treatment Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Acrotech Biopharma Inc
    matched search terms
    1. myeloma
    package ndcs
    1. 72893-001-01
    product ndcs
    1. 72893-001
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage, Palliative Treatment ( 1.2 ) Removed 8/2021 Dosage and Administration ( 2.2 , 2.3 , 2.4 ) 11/2021 Warnings and Precautions ( 5.1 , 5.2 ) 8/2021
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 311487
    2. 1745090
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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.
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    spl effective date
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    spl effective time
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    spl set id
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    substance names
    1. MELPHALAN HYDROCHLORIDE
    uniis
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    verification flags
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    Drugs@FDA application source records
    1. application number
      NDA207155
      payload
      all indexed label documents
      1. Appl No
        207155
        Application Docs Date
        2016-03-15 00:00:00
        Application Docs ID
        19960
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
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      2. Appl No
        207155
        Application Docs Date
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        Application Docs ID
        50934
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
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      3. Appl No
        207155
        Application Docs Date
        2021-08-11 00:00:00
        Application Docs ID
        68345
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      4. Appl No
        207155
        Application Docs Date
        2022-05-03 00:00:00
        Application Docs ID
        70948
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
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      all submission records
      1. Appl No
        207155
        Review Priority
        STANDARD
        Submission Class Code ID
        15
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2016-03-10 00:00:00
        Submission Type
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        Submissions Public Notes
      2. Appl No
        207155
        Review Priority
        N/A
        Submission Class Code ID
        4
        Submission No
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        Submission Status
        AP
        Submission Status Date
        2017-09-25 00:00:00
        Submission Type
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        Submissions Public Notes
      3. Appl No
        207155
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2016-03-10 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      4. Appl No
        207155
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2021-08-09 00:00:00
        Submission Type
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        Submissions Public Notes
      5. Appl No
        207155
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2022-04-26 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA207155
      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
      2022-04-26
      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
        207155
        Application Docs Date
        2022-05-03 00:00:00
        Application Docs ID
        70948
        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
      207155
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      ACROTECH BIOPHARMA
      openfda application present
      true
      products
      1. Active Ingredient
        MELPHALAN HYDROCHLORIDE
        Appl No
        207155
        Drug Name
        EVOMELA
        Form
        POWDER;INTRAVENOUS
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        EQ 50MG BASE/VIAL
        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. EVOMELA
    classification reasons
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    clinical review status
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    true
    exact text
    1 INDICATIONS AND USAGE Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. ( 1.1 ) 1.1 Multiple Myeloma-Conditioning Treatment Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with m
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    1. MELPHALAN
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    positive predicate support span
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    exact text
    is an alkylating drug indicated
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    qualifier mentions
    1. context exact
      1 INDICATIONS AND USAGE Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenit
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        1 INDICATIONS AND USAGE Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
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        spl effective date
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        Source null
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        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        tumor_directed_candidate
        Passage 2 · unclassified context
        application numbers
        1. NDA207155
        brand names
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        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
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        content role
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        context span
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        414
        end exclusive
        true
        exact text
        ATIONS AND USAGE Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. ( 1.1 ) 1.1 Multiple Myeloma-Conditioning Treatment Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple
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        positive predicate support span
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              source url
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              spl effective date
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              regimen
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              Passage 3 · positive indication candidate
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              ND USAGE Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. ( 1.1 ) 1.1 Multiple Myeloma-Conditioning Treatment Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
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                    exact text
                    1.1 Multiple Myeloma-Conditioning Treatment Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
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                    source url
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                    structured fields status
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                    biomarker and test
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                    disease stage
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                    limitations
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                    line
                    Source null
                    prior therapy
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                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
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                    Preserved source evidence · Not medical advice