Food and Drug Administration

Dermatologic & Ophthalmic Drugs Advisory Committee

and the Drug Safety and Risk Management Advisory Committee

July 12, 2004

Slides

Introduction to Psoriasis, Dr. Denise Cook, MD, FDA (HTM) (PPT)

Tazarotene Capsules in the Treatment of Psoriasis, Dr. Patricia Walker, MD, PhD, Allergan (HTM) (PPT)

Allergan, Inc. NDA 21-701 Tazarotene 1.5 and 4.5 mg Capsules Backup Slides (HTM) (PPT)

Toxicology Studies of Tazarotene, Dr. Jiaqin Yao, PhD, FDA (HTM) (PPT)

Teratogenic Risk From Tazarotenic Acid in Semen, Dr. Yao, FDA (HTM) (PPT)

Clinical Pharmacology and Biopharmaceutics Presentation for Oral Tazarotene (NDA 21-701), Dr. Tapash Ghosh, PhD, FDA (HTM) (PPT)

Clinical Safety Oral Tazarotene NDA 21-701, Dr. Denise Cook, MD, FDA (HTM) (PPT)

Backup Slide Hypertriglyceridemia, Dr. Denise Cook, MD, FDA (HTM) (PPT)

Biostatistical Analysis of Pivotal Studies, Dr. Shiowjen Lee, PhD, FDA (HTM) (PPT)

Teratogenic Risk From Tazarotenic Acid in Semen, Dr. Lee, FDA (HTM) (PPT)

Clinical Wrap-Up, Dr. Denise Cook, MD, FDA (HTM) (PPT)

Evolution of Risk Management for Systemic Retinoids, Dr. Jill Lindstrom, MD, FDA (HTM) (PPT)

Potential Risk Management Tools for Oral Tazarotene: Context, Considerations, and Experience, Dr. Anne Trontell, MD, MPH, FDA (HTM) (PPT)

Open Public Hearing

Open Public Hearing Speakers (HTM) (PPT)

Statement From Dale White, National Psoriasis Foundation (HTM) (PPT)

Written Statement From Dale White, National Psoriasis Foundation (HTM) (PDF) (Word)

Statement of Janey Freeman (HTM) (PDF) (Word)

Statement of Tyrone Gorre (HTM) (PDF) (Word)