Food and Drug Administration

Pediatric Advisory Committee

February 14, 2005

Briefing Information

Overview Memorandum (HTM) (PDF)(Word)

Benazepril (Lotensin®)

Adverse Event Review (PDF)

Drug Use Data (PDF)

Medical Review (PDF)

Clinical Pharmacology & Biopharmaceutics Review (PDF)

Lotensin® (benazelpril hydrochloride) Label (PDF)

Esmolol

Adverse Event Review (PDF)

Drug Use Data (PDF)

Medical Officer Executive Summary (PDF)

Clinical Pharmacology & Biopharmaceutics Review (PDF)

Esmolol Hydrochloride Injection Label (PDF)

Orlistat (Xenical®)

Safety Review (PDF)

Drug Use Data (PDF)

Executive Summary (PDF)

Clinical Review (PDF)

Xenical® (orlistat) Capsules (PDF)

Glucovance® (glyburide/metformin)

Safety Review (PDF)

Drug Use Data (PDF)

Executive Summary (PDF)

Clinical Pharmacology & Biopharmaceutics Review (PDF)

Glucovance® (Glyburide/Metformin HCI Tablets) Label (PDF)

Atovaquone/Proguanil (Malarone®)

Adverse Event Review (PDF)

Drug Use Data (PDF)

Summary of Clinical Review (PDF)

BPCA Summary Review (PDF)

Malarone® (atovaquone and proguanil hydrochloride) Tablets and Malarone® (atovaquone & proguanil hydrohloride) Pediatric Tablets Label (PDF)

Nelfinavir Tablets and Oral Powder (Viracept®)

Adverse Event Review (PDF)

Drug Use Data (PDF)

Clinical Review (PDF)

Clinical Pharmacology & Biopharmaceutics Review (PDF)

Viracept® (nelfinavir mesyate) Tablets and Oral Powder Label (PDF)