NDA 21-242 Rectal Artesunate

7/19/02


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Table of Contents

NDA 21-242 Rectal Artesunate

Proposed Indication

Implications of the Indication

SAFETY SUBMISSIONS

WHO-sponsored Studies

WHO-sponsored Studies

WHO-sponsored Studies: Clinical

WHO-sponsored Studies: AE

WHO-sponsored studies: Deaths

WHO-sponsored Studies: Labs

WHO-sponsored studies : Dose

WHO-sponsored Studies: Special Populations

WHO-sponsored Studies: Safety Summary

Safety Review of Published and Unpublished Clinical Studies on Artemisinin Derivatives

WHO- Safety Review: Types of Clinical Studies

WHO-Safety Review: Disease Population

WHO-Safety Review: Adverse Events

WHO-Safety Review: Laboratory and ECG Abnormalities

WHO-Safety Review: Neurological Assessments

WHO-Safety Review: reassurance

WHO-Safety Review: problems

Artemisinin Neurotoxicity

Preclinical evidence: neurotoxicity margin of safety

Preclinical evidence: margin of safety

Neurotoxicity: clinical experience

Neurotoxicity: What do we know

Neurotoxicity: What we donít know

Lack of information: populations Can we make the link?

Safety Summary: Benefit / Risk

Safety Summary: Benefit/Risk

Author: CDER USER