Approvals (Drugs@FDA)

PIXCLARA

TELIX PHARMACEUTICALS US INC · FLORETYROSINE F 18

NDA218592Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218592
Sponsor name
TELIX PHARMACEUTICALS US INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260911
    Review priority
    PRIORITY
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      87194
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218592Orig1s000lbl.pdf
      Date
      20260915
      Type
      Label
    2. ID
      87195
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218592Orig1s000ltr.pdf
      Date
      20260915
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    PIXCLARA
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      FLORETYROSINE F 18
      Strength
      185MBQ to 259MBQ
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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.