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OSP finalist
Action period
  1. Summary Review

    Action date:
    FDA Application:
    NDA207533
    Drug:
    Aristada
    Active Ingredients:
    Aripiprazole lauroxil
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 5330rig15000 SUMMARY REVIEW...
    • ...A DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH...
  2. Label

    Action date:
    FDA Application:
    NDA207501
    Drug:
    Cresemba
    Active Ingredients:
    Isavuconazonium sulfate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CRESEMBA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Invasive Aspergillosis CRESEMBA is an azole antifungal indicated for patients 18 years...
  3. Letter

    Action date:
    FDA Application:
    NDA207501
    Drug:
    Cresemba
    Active Ingredients:
    Isavuconazonium sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207500/S-001 NDA 207501/S-001 SUPPLEMENT APPROVAL...
    • ...NDA 207501/S-001 Page 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of labeling must be identical...
  4. Label

    Action date:
    FDA Application:
    NDA207501
    Drug:
    Cresemba
    Active Ingredients:
    Isavuconazonium sulfate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CRESEMBA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Invasive Aspergillosis CRESEMBA is an azole antifungal indicated for patients 18 years...
  5. Letter

    Action date:
    FDA Application:
    NDA207501
    Drug:
    Cresemba
    Active Ingredients:
    Isavuconazonium sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207501 NDA APPROVAL Astellas Pharma US Inc...
    • ...NDA 207501 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical...
  6. Summary Review

    Action date:
    FDA Application:
    NDA207501
    Drug:
    Cresemba
    Active Ingredients:
    Isavuconazonium sulfate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207500Orig1s000 / 207501Orig1s000 LABELING...
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CRESEMBA safely and effectively. See full...
  7. Label

    Action date:
    FDA Application:
    NDA207500
    Drug:
    Cresemba
    Active Ingredients:
    Isavuconazonium sulfate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CRESEMBA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Invasive Aspergillosis CRESEMBA is an azole antifungal indicated for patients 18 years...
  8. Letter

    Action date:
    FDA Application:
    NDA207500
    Drug:
    Cresemba
    Active Ingredients:
    Isavuconazonium sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207500/S-001 NDA 207501/S-001 SUPPLEMENT APPROVAL...
    • ...NDA 207501/S-001 Page 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of labeling must be identical...
  9. Letter

    Action date:
    FDA Application:
    NDA207369
    Drug:
    Abacavir; lamivudine
    Active Ingredients:
    Abacavir;lamivudine
    • ...Wu DEPARTMENT OF HEALTH AND HUMAN SERVICES a Food and Drug Administration Silver Spring MD 20993 NDA 207369 TENTATIVE APPROVAL Hetero USA, Inc...
    • ...NDA 207369 Page 2 (4) (4) submission includes ?nal printed labeling (FPL) We have not reviewed this FPL. You are responsible for assuring...
  10. Label

    Action date:
    FDA Application:
    NDA207318
    Drug:
    Nuplazid
    Active Ingredients:
    Pimavanserin tartrate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUPLAZID safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related...