Food and Drug Administration
Pediatric Advisory Subcommittee
June 9, 2004
Briefing Information
Cover Memorandum, Dr. Solomon Iyasu, MD, MPH, FDA (HTM) (PDF) (Word)
Label - Allegra® (Fexofenadine Hydrochloride) Capsules and Tablets (PDF)
Allegra® (Fexofenadine Hydrochloride) Capsules and Tablets Recommendations and Summary of Clinical Findings (PDF)
Allegra® (Fexofenadine Hydrochloride) Capsules and Tablets Clinical Pharmacology and Biopharmaceutics Summary (PDF)
Prescribing Information - Hycamtin® (Topotecan Hydrochloride) for Injection (HTM) (PDF) (Word)
Hycamtin® (Topotecan Hydrochloride) for Injection - Clinical Pharmacology and Biopharmaceutics, Executive Summary (PDF)
Clinical Review of Labeling Supplement with Clinical Data (PDF)
Product Information - Temodar® (Temozolomide) Capsules (PDF)
Temodar® (Temozolomide) Capsules - Clinical Review, Executive Summary Section (PDF)
Temodar® (Temozolomide) Capsules - Clinical Pharmacology and Biopharmaceutics Review (PDF)
Label - Vigamox™ (Moxifloxacin Hydrochloride Ophthalmic Solution) 0.5% as Base (PDF)
Label - Ciloxan® (Ciprofloxacin Hydrochloride Ophthalmic Ointment) 0.3% as Base (PDF)
Ciloxan® (Ciprofloxacin Hydrochloride Ophthalmic Ointment) - BPCA Summary of NDA 19-992/SE5-017 (PDF)
Label - Monopril® (Fosinopril Sodium Tablets) (PDF)
Monopril® (Fosinopril Sodium Tablets) - Medical Review (PDF)
Monopril® (Fosinopril Sodium Tablets) - Clinical Pharmacology and Biopharmaceutics Review (PDF)
Label - Duragesic® (Fentanyl Transdermal System) (PDF)
Duragesic® (Fentanyl Transdermal System - Executive Symmary of Clinical and Clinical Pharmacology and Biopharmaceutics Review (PDF)
Label - Effexor® (Venlafaxine Hydrochloride) Tablets (PDF)
Label - Effexor® (Venlafaxine Hydrochloride) Extended-Release Capsules (PDF)
Effexor® (Venlafaxine Hydrochloride) - Clinical Review, Executive Summary Section (PDF)
Effexor® (Venlafaxine Hydrochloride) - Summary of Clinical Pharmacology and Biopharmaceutics Findings (PDF)
Bibliography (HTM) (PDF) (Word)
The Pediatric Research Equity Act of 2003 (PDF)
Prepublication Copy of the Ethical Conduct of Clinical Research Involving Children (PDF)