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OSP finalist
Action period
  1. Environmental Assessment

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 ENVIRONMENTAL ASSESSMENT...
    • ...Helsinn Healthcare SA submitted a claim of categorical exclusion from the requirement to prepare an environmental assessment (EA) for AKYNZEO. AKYNZEO...
  2. Clinical Pharmacology Biopharmaceutics Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S...
    • ...  NDA 205-718 Office of Clinical Pharmacology Review_PART2 INDIVIDUAL STUDY RESULTS and REVIEWER’s COMMENTS   Study NETU-09-21: Oral ADME Study...
  3. Chemistry Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057180rig15000 CHEMISTRY...
    • ...MEMORANDUM PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE: September 16, 2014 FROM: Raymond P...
  4. Cross Discipline Team Leader Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW...
    • ...Cross-Discipline Team Leader Review Date September 9, 2014 From Ruyi He, MD Subject ross-Discipline Team Leader...
  5. Office Director Memo

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 OFFICE DIRECTOR MEMO...
    • ...MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE...
  6. Officer/Employee List

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 OFFICER/EMPLOYEE LIST...
    • ...Officer/Employee List for NDA 205718 Akynzeo (netupitant/palonosetron) "The following officers or employees of FDA participated in the decision...
  7. Label

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated...
  8. Printed Labeling

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057180rig15000 LABELING...
    • ...HIGHLIGHTS OF PRESCRIBING INFORVIATION These highlights do not include all the information needed to use safely and effectively. See full prescribing...
  9. Letter

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205718 NDA APPROVAL Helsinn Healthcare SA c/o August...
    • ...NDA 205718 Page 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of labeling must be identical...
  10. Medical Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057180rig15000 MEDICAL...
    • ...Addendum to Medical Officer’s Review Application: NDA 205718 Drug: Akynzeo (Netupitant + Palonosetron Fixed Dose Combination) Sponsor: Helsinn...