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OSP finalist
Action period
  1. Risk Assessment and Risk Mitigation Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S...
    • ...Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office...
  2. Approval Letter

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 205677Orig1s000 Trade Name: Hetlioz Generic Name: Tasimelteon...
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH 205677Orig1s000 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter Other Action...
  3. Clinical Pharmacology Biopharmaceutics Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S...
    • ...BIOPHARMACEUTICS REVIEW - ADDENDUM Of?ce of New Drug Quality Assessment Application No.: NDA 205-677 Reviewer...
  4. Chemistry Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...is lit ?2...
    • ...Hetlioz (tasimelteon) Capsules NDA 205677 Summary Basis for Recommended Action from Chemistry, Manufacturing, and Controls Applicant: Vanda...
  5. Cross Discipline Team Leader Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW...
    • ...Cross Discipline Team Leader Review- Addendum Ronald Farkas. MD. Cross-Discipline Team Leader Review - Addendum Date...
  6. Office Director Memo

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 OFFICE DIRECTOR MEMO...
    • ...Office Director Decisional Memo Date 31 January 2014 From Ellis F. Unger, MD Director, Of?ce of Drug Evaluation 1 Subject...
  7. Officer/Employee List

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 OFFICER/EMPLOYEE LIST...
    • ...Officer/Employee List Application: 205677 The following officers or employees of FDA participated in the decision to approve this application...
  8. Label

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full...
    • ...______________________________________________________________________________ FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE HETLIOZ...
  9. Printed Labeling

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ......
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full...
  10. Letter

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205677 NDA APPROVAL Vanda Pharmaceuticals, Inc. 2200...
    • ...NDA 205677 Page 2 We have completed our review of this application. It is approved, effective on the date of this letter, for use as recommended...