Approvals (Drugs@FDA)

BEXLUTRY

CURIUM · LUTETIUM LU 177 DONATATE

NDA218525Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218525
Sponsor name
CURIUM
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260914
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      87203
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218525Orig1s000ltr.pdf
      Date
      20260915
      Type
      Letter
    2. ID
      87235
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218525Orig1s000lbl.pdf
      Date
      20260922
      Type
      Label
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    BEXLUTRY
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      LUTETIUM LU 177 DONATATE
      Strength
      370MBQ/ML
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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.