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OSP finalist
Action period
  1. Proprietary Name Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 PROPRIETARY NAME REVIEW(S...
    • ...PROPRIETARY NAME REVIEW Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM...
  2. Other Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 OTHER...
    • ...Development Template This template should be completed by the Development Coordinator and included for each in the Action Package. 205755...
  3. Pharmacology Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 PHARMACOLOGY REVIEW(S...
    • ...MEMORANDUM Zykadia (ceritinib) Date: April 9, 2014 To: File for NDA 205755 From: John K. Leighton, PhD, DABT Acting Director, Division of Hematology...
  4. Summary Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ......
    • ...Division Director Summary Review Date April 18, 2014 From Patricia Keegan Subject Division Director Srunmary Review NDA...
  5. Statistical Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 STATISTICAL REVIEW(S...
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES ?6 Public Health Service an Food and Drug Administration Center for Drug Evaluation and Research Memorandum...
  6. Label

    Action date:
    FDA Application:
    NDA205750
    Drug:
    Cholbam
    Active Ingredients:
    Cholic acid
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CHOLBAM® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Bile Acid Synthesis Disorders due to Single Enzyme Defects CHOLBAM is indicated...
  7. Letter

    Action date:
    FDA Application:
    NDA205750
    Drug:
    Cholbam
    Active Ingredients:
    Cholic acid
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205750 NDA APPROVAL Asklepion Pharmaceuticals, LLC...
    • ...NDA 205750 Page 2 We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use...
  8. Label

    Action date:
    FDA Application:
    NDA205747
    Drug:
    Humalog kwikpen
    Active Ingredients:
    Insulin lispro recombinant
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HUMALOG safely and effectively. See full...
    • ...8.5 8.6 8.7 Geriatric Use Renal Impairment Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action...
  9. Letter

    Action date:
    FDA Application:
    NDA205747
    Drug:
    Humalog kwikpen
    Active Ingredients:
    Insulin lispro recombinant
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205747 NDA APPROVAL Eli Lilly and Company Attention...
    • ...NDA 205747 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...
  10. Label

    Action date:
    FDA Application:
    NDA205739
    Drug:
    Veltassa
    Active Ingredients:
    Patiromer sorbitex calcium
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VELTASSA™ safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: BINDING TO OTHER ORAL MEDICATIONS Veltassa binds to many orally administered medications, which could decrease...