ONCOLOGIC DRUGS ADVISORY COMMITTEE

December 13, 2000

Slides

NDA 20-726/S-006, FEMARA (letrozole) TABLETS
(First-Line Breast Cancer Indication)

FDA

Introduction, John Johnson, MD, FDA   ppt   html

FDA Presentation, Martin Cohen, MD, FDA   ppt   html

NOVARTIS

Introduction, Mathias Hukkelhoven, PhD

Hormonal Therapy of Breast Cancer, Harold A Harvey, MD

Pharmacology of Letrozole, Ajay S Bhatnager, PhD

Clinical Program, Margaret Dugan, MD

NDA 21-240, Histamine Hydrochloride Injection

Sponsor Presentation, MAXIM Pharmaceuticals   ppt   html

FDA

FDA Review, Judy H Chian, MD   ppt   html

Areas of Major Statistical Concerns in the M01 Study, Rajeshwari Sridhara, PhD   ppt   html

Study MP-US-M01, Donna Griebel, MD   ppt