Food and Drug Administration
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)