ADVAIR and FLOVENT DISKUS Supplements for the COPD indication: SUMMARY and QUESTIONS Mary Purucker, MD, PhD Medical Team Leader Division of Pulmonary and Allergy Drug Products CDER, USFDA

1/17/02


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Table of Contents

ADVAIR and FLOVENT DISKUS Supplements for the COPD indication: SUMMARY and QUESTIONS Mary Purucker, MD, PhD Medical Team Leader Division of Pulmonary and Allergy Drug Products CDER, USFDA

OVERVIEW

EFFICACY SUMMARY

SAFETY ISSUES

ICS and COPD: AERS Database

ICS Systemic Effects: Bone (1)

ICS Systemic Effects: Bone (2)

ICS Systemic Effects: HPA Axis

ICS Systemic Effects: Ocular

Conclusions

Agency Concerns for Discussion by PADAC: EFFICACY

Agency Concerns for Discussion by PADAC: SAFETY

Acknowledgements

Author: Tunde Otulana