Approvals (Drugs@FDA)

BKEMV

AMGEN INC · ECULIZUMAB-AEEB

BLA761333Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761333
Sponsor name
AMGEN INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240528
    Review priority
    STANDARD
    Submission class code
    TYPE 2
    Submission class code description
    Type 2 - New Active Ingredient
    Application docs
    1. ID
      78567
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s000lbl.pdf
      Date
      20240528
      Type
      Label
    2. ID
      78572
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761333Orig1s000ltr.pdf
      Date
      20250204
      Type
      Letter
    3. ID
      79112
      Url
      https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=431
      Date
      20240718
      Type
      REMS
    4. ID
      80961
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761333Orig1s000TOC.html
      Date
      20250205
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20260326
    Review priority
    N/A
    Submission class code
    REMS
    Submission class code description
    REMS
    Application docs
    1. ID
      85593
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761333Orig1s007ltr.pdf
      Date
      20260330
      Type
      Letter
  3. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20251124
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      84305
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761333Orig1s005ltr.pdf
      Date
      20251125
      Type
      Letter
    2. ID
      84316
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761333s005lbl.pdf
      Date
      20251125
      Type
      Label
    3. ID
      84317
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761333s005lbl.pdf#page=31
      Date
      20251125
      Type
      Medication Guide
  4. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20250130
    Review priority
    N/A
    Submission class code
    REMS
    Submission class code description
    REMS
    Application docs
    1. ID
      81108
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761333Orig1s003ltr.pdf
      Date
      20250206
      Type
      Letter
  5. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20241023
    Review priority
    STANDARD
    Submission class code
    BIOSIMILAR
    Application docs
    1. ID
      79974
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761333Orig1s001ltr.pdf
      Date
      20241024
      Type
      Letter
    2. ID
      79984
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s001lbl.pdf
      Date
      20241025
      Type
      Label
  6. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20260629
    Review priority
    N/A
    Submission class code
    BIOEQUIV
    Submission class code description
    Bioequivalence
    Application docs
    1. ID
      86422
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761333Orig1s008ltr.pdf
      Date
      20260702
      Type
      Letter
    2. ID
      86470
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761333s008lbl.pdf
      Date
      20260706
      Type
      Label
  7. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20250917
    Review priority
    N/A
    Submission class code
    REMS
    Submission class code description
    REMS
    Application docs
    1. ID
      83386
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761333Orig1s006ltr.pdf
      Date
      20250918
      Type
      Letter
  8. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20250418
    Review priority
    N/A
    Submission class code
    REMS
    Submission class code description
    REMS
    Application docs
    1. ID
      82031
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761333Orig1s004ltr.pdf
      Date
      20250428
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BKEMV
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      ECULIZUMAB-AEEB
      Strength
      300MG/30ML(10MG/ML)
Harmonized identifiers (openFDA)
Application number
BLA761333
Brand name
BKEMV
Generic name
ECULIZUMAB-AEEB
Manufacturer name
Amgen Inc
Product NDC
55513-180
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
ECULIZUMAB
RxCUI
2706351, 2706358
SPL ID
d7cfaa27-0f0d-4f4f-934d-32be84291d85
SPL set ID
002f9748-b0e8-4b6e-a38b-56930a839491
Package NDC
55513-180-01
Nui
N0000175575, N0000175974
Pharm class epc
Complement Inhibitor [EPC]
Pharm class moa
Complement Inhibitors [MoA]
UNII
A3ULP0F556
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.