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OSP finalist
Action period
  1. Clinical Pharmacology Biopharmaceutics Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S...
    • ...NDA 205 755, Biophannaceutics Assessment BIOPHARMACEUTICS REVIEW Of?ce...
  2. Chemistry Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 CHEMISTRY...
    • ...Zykadia (ceritinib) Capsules NDA 205755 Summary Basis for Recommended Action from Chemistry, Manufacturing, and Controls Applicant: Novaltis...
  3. Cross Discipline Team Leader Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW...
    • ...Cross Discipline Team Leader Review Gideon Blurnenthal. MD Ceritinib NDA 205755 Cross-Discipline Team Leader Review Date April 11...
  4. Office Director Memo

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 OFFICE DIRECTOR MEMO...
    • ...Of?ce Director Summary Review NDA 205755 Zykadia (ceritinib) Of?ce Director Decisional Memo for Regulatory Action Date...
  5. Officer/Employee List

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 OFFICER/EMPLOYEE LIST...
    • ...Public Health Service Food and Drug Administration Center for Drug Evaluation and Research $44 DEPARTMENT OF HEALTH AND HUMAN SERVICES Of?cer...
  6. Label

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZYKADIA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK...
  7. Printed Labeling

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 LABELING...
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZYKADIA safely and effectively. See full...
  8. Letter

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205755 ACCELERATED APPROVAL Novartis Pharmaceuticals...
    • ...NDA 205755 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21...
  9. Medical Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 MEDICAL...
    • ...Clinical Investigator Financial Disclosure Review Template Application Number: NDA 205755 Submission Date(s): 12/24/13 Applicant: Novartis Product...
  10. Microbiology/Virology Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S...
    • ...MEMORANDUM f? 0% DEPARTMENT OF HEALTH AND HUMAN SERVICES 5 PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION l} CENTER FOR DRUG EVALUATION...